Information Notice 2003-09, Source Positioning Errors and System Malfunctions Administration of Intravascular Brachytherapy
| ML031830015 | |
| Person / Time | |
|---|---|
| Issue date: | 07/16/2003 |
| From: | Chris Miller NRC/NMSS/IMNS |
| To: | |
| References | |
| IN-03-009 | |
| Download: ML031830015 (10) | |
UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
WASHINGTON, D.C. 20555-0001 July 16, 2003 NRC INFORMATION NOTICE 2003-09: SOURCE POSITIONING ERRORS AND SYSTEM
MALFUNCTIONS DURING ADMINISTRATION OF
INTRAVASCULAR BRACHYTHERAPY
Addressees
All medical licensees.
Purpose
The U.S. Nuclear Regulatory Commission (NRC) is issuing this information notice (IN) to inform
addressees of four recently reported medical events, with two separate device types, that have
occurred during the conduct of intravascular brachytherapy (IVB) procedures. These medical
events involved errors in positioning the IVB sources or system malfunctions, resulting in
administration of the dose to the wrong treatment site. Two events involved inadequate
understanding of source positioning details for the most recent device being employed. The
third event involved catheter malfunction and inadequate visualization of the active source and
the fourth event involved system malfunction.
It is expected that recipients will review this information for applicability to their licensed
operations and consider actions, as appropriate, to avoid similar problems. However, suggestions contained in this IN are not new NRC requirements; therefore, no specific action
nor written response is required.
Description of Circumstances
NRC has received four recent medical event reports involving administration of IVB doses to
the wrong treatment sites. The events are summarized below.
In the first event, the licensee had been using a Guidant Galileo IVB system and had recently
received an upgraded software system, the Guidant Galileo III. The old system was updated, in
part, to allow delivery of the dose in two parts to the distal and proximal ends of the lesion. The
new system automatically sends out an inactive wire with a marker that should align with a
marker on the catheter placed in the patient. To reach exact alignment, the user may need to
manually fine tune the positioning. With the old system, the positioning is accomplished
essentially the same way. On the day of the first use of the upgraded system, the vendors
representative arrived on site to provide training. However, the first patient had already been
prepped to undergo the treatment and the formal training for the new version was not delivered
prior to the treatment. During the initial use of the upgraded system, the source delivery unit
sent out the inactive wire to a point where its distal marker stopped in the approximate area of
the catheters distal marker. Since the users had not received formal training, nor had they
reviewed the training manual, they questioned whether they had to manually fine tune the
positioning of the inactive wire to align it with the distal end of the catheter. The vendors
representative had not used the upgraded system often and did not fully understand the
importance of the marker alignment, and therefore, assured the users that the position of the
inactive wire was acceptable and that the system would advance the active wire to cover the
desired area without any fine tuning. As a result, when the source delivery unit sent out the
active wire, the wire traveled 3 to 6 millimeters short of its intended location. The users retracted
the source, were again assured by the vendors representative that the active wire would go to
the desired position, and attempted to treat again. The active source wire was run out a second
time and again did not reach the desired treatment position. Subsequently, the inactive wire
was run out and this time the users manually adjusted it to align with the catheters distal
marker, and the treatment was administered.
In the second event, the licensee had been using the Novoste Beta-Cath 5 French IVB system
and had recently received the 3.5 French system. One of the differences between the two units
is the method for locating positional markers. The vendors representative was present for the
procedure and had provided training to the licensees staff prior to staff performing a patient
treatment with the new unit. However, both the vendors representative and the Authorized
User were in the room but not in a position to see the source train positioning in the new
catheter which was inserted by the interventional cardiologist. Following insertion of the active
source train, the interventional cardiologist determined, via fluoroscopy, that the source train
was incorrectly positioned and did not cover the desired treatment site. The source train was
withdrawn after 60 seconds of treatment. The catheter was then correctly positioned and
treatment was given to the proper area of the vessel.
In the third event, during a treatment with a Novoste Beta-Cath 3.5 French IVB system, the
source train did not travel the entire way to the treatment site and was 40 millimeters proximal
to the treatment site. The immediate cause of the event was a small kink in the delivery
catheter which kept the source train from traveling to the correct site, even though the kink was
not substantial enough to affect the flow of the sterile water used to send/retrieve the sources.
The error was identified the next day during the medical physics quality assurance checks of
the films taken during the treatment. The review revealed that the proximal end of the source
train was hidden inside the guiding catheter and was not properly visualized by fluoroscopy
during source placement. The licensee also noted that the proximal and distal markers of the
source train are the same size and shape and are not distinguishable from each other.
Therefore, the distal end of the source train was mistaken as the proximal end and the entire
dose was delivered to an area 40 millimeters proximal to the intended treatment site. During
on-site review of the event, NRC inspectors observed the licensee conducting a treatment with
the 3.5 French IVB system. Again, the licensee had to remove the catheter from the patient, due to kinking of the catheter. As in the earlier treatment, the kinking was not substantial
enough to affect the flow of the sterile water. However, the source train remained stuck in the
catheter, requiring removal of the catheter containing the source train from the patient. The
manufacturer is evaluating the system. In the fourth event, there was a malfunction of the drive mechanism with a Guidant Galileo III
IVB system. A vendors representative was present for the treatment. During the treatment the
inactive source successfully reached the proper position (confirmed visually via fluoroscopy)
and returned. The active source was then advanced into the catheter. The licensee noted that
the source movement light continued to blink well after the anticipated transit time. The
licensee attempted to locate the source position via fluoroscopy; however, the source was not
viewed. The licensee performed surveys that confirmed that the source stopped inside the
patient. The licensee assumed a machine malfunction had occurred and initiated emergency
procedures. The indicator light on the console continued to indicate the source was in transit
even after the licensee confirmed the source was in the patient and not at the treatment site.
While attempting to return the source to the shielded position, the licensee was unable to
retract the source using the machine interrupt, the system stop button, or the manual
hand-wheel. Therefore, the licensee manually removed the catheter and source from the
patient. After the power cord was removed from the wall receptacle, the source was retracted
back to its shielded position. The device is being evaluated for proper operation by the
manufacturer. In addition, the licensee did not contact the State regulatory authority, as
required.
Discussion:
In two of the four cases, the licensees received new designs for systems they had been using, and did not fully appreciate any differences in the methods used by the new designs for
positioning the active source trains. In addition, a vendors representative was present in both
cases, but in one case, the representative did not fully understand the source positional
differences between systems, and in the other case, the representative could not adequately
view the treatment to verify whether correct positional methods were used.
In another case, two issues resulted in the wrong area being treated. First, the catheter kinked, restricting the source train from traveling to the intended treatment site. Second, the proximal
and distal markers for the source train are the same size and shape. During fluoroscopy of the
treatment area for source placement verification, the licensees staff believed that both the
proximal and distal markers had been visualized. However, only the distal marker had been
visualized.
In the last case, there was complete failure in safety systems when emergency procedures
were implemented. The system appears to have malfunctioned both in its ability to recognize
the location of the active source and its ability to retract the active source wire with emergency
features. Although investigation of this reported event is ongoing, presently available
information suggests that the console touch screen used to control the treatment froze and
did not display the touch screen interrupt button. In addition, the licensee did not notify the
regulatory authority of this event. Prompt notification of regulatory authorities is essential for
these types of events to ensure that immediate actions are taken to prevent recurrences of
such medical events by this and other device users.
Licensees performing IVB are expected to review this IN and:
- Assure that vendor training has been provided to all users prior to their actual use of
new devices or re-designs of devices; * Encourage device users to review all of the vendors training documentation and clarify
any concerns with the vendors regarding particular devices prior to using the devices for
patient treatments. If direction provided by the on-site vendors representatives is
believed to be in error, licensees are expected to clarify any discrepancies with the
manufacturers prior to use.
- Report all system malfunctions to the vendors; and if required, to the licensing
authorities expeditiously; and
- Consider performing quality assurance checks of the films taken during the treatment to
identify whether correct placements of active sources were achieved.
This IN requires no specific action nor written response. If you have any questions about the
information in this notice, please contact the technical contacts below, or the appropriate
regional office.
/RA/
Charles L. Miller, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material Safety
and Safeguards
Technical Contacts: Penny Lanzisera, Region I Thomas K. Thompson, Region I
610-337-5169 610-337-5303 E-mail: pan@nrc.gov E-mail: tkt@nrc.gov
Attachments:
1. List of recently issued NMSS Information Notices
2. List of recently issued NRC Information Notices * Encourage device users to review all of the vendors training documentation and clarify
any concerns with the vendors regarding particular devices prior to using the devices for
patient treatments. If direction provided by the on-site vendors representatives is
believed to be in error, licensees are expected to clarify any discrepancies with the
manufacturers prior to use.
- Report all system malfunctions to the vendors; and if required, to the licensing
authorities expeditiously; and
- Consider performing quality assurance checks of the films taken during the treatment to
identify whether correct placements of active sources were achieved.
This IN requires no specific action nor written response. If you have any questions about the
information in this notice, please contact the technical contacts below, or the appropriate
regional office.
/RA/
Charles L. Miller, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material Safety
and Safeguards
Technical Contacts: Penny Lanzisera, Region I Thomas K. Thompson, Region I
610-337-5169 610-337-5303 E-mail: pan@nrc.gov E-mail: tkt@nrc.gov
Attachments:
1. List of recently issued NMSS Information Notices
2. List of recently issued NRC Information Notices
DISTRIBUTION:
ADAMS Accession#: ML031830015 DOCUMENT NAME: g:\IMNS\Turner\infonotice ivb rev.wpd *See previous concurrence
OFC MSIB NMSS MSIB MSIB IMNS
NAME ATurner* EKraus* (fax) RZelac* TEssig* CMiller
DATE 7/1/03 6/24/03 7/1/03 7/2/03 7/16/03 OFFICIAL RECORD COPY
Attachment 1 LIST OF RECENTLY ISSUED
NMSS INFORMATION NOTICES
_____________________________________________________________________________________
Information Date of
Notice No. Subject Issuance Issued to
_____________________________________________________________________________________
2002-31, Sup 1 Potentially Defective UF6 03/24/2003 All U.S. Nuclear Regulatory
Cylinder Valves (1-inch) Commission (NRC) licensees
authorized to possess and use
source material and/or special
nuclear material for heating, emptying, filling, or shipping 30-
and 48-inch cylinders of uranium
hexafluoride (UF6).
2002-36 Incomplete or Inaccurate 12/27/2002 All materials and fuel cycle
Information Provided to the licensees and certificate holders.
Licensee and/or NRC By Any
Contractor or Subcontractor
Employee
2002-35 Changes to 10 CFR Parts 71 12/20/2002 All holders of 10 CFR Part 71 and 72 Quality Assurance quality assurance program
Programs approvals and all 10 CFR Part 72 licensees and certificate holders
2002-33 Notification of Permanent 11/21/2002 All teletherapy and radiation
Injunction Against Neutron processing licensees.
Products Incorporated of
Dickerson, Maryland
2002-31 Potentially Defective UF6 10/31/2002 All licensees authorized to
Cylinder Valves (1-inch) possess and use source material
and/or special nuclear material for
the heating, emptying, filling, or
shipping of uranium hexafluoride
(UF6) in 30- and 48-inch
cylinders.
Note: NRC generic communications may be received in electronic format shortly after they are issued by
subscribing to the NRC listserver as follows:
To subscribe send an e-mail to <listproc@nrc.gov >, no subject, and the following command in the
message portion:
subscribe gc-nrr firstname lastname
______________________________________________________________________________________
OL = Operating License
CP = Construction Permit
Attachment 2 LIST OF RECENTLY ISSUED
NRC INFORMATION NOTICES
_____________________________________________________________________________________
Information Date of
Notice No. Subject Issuance
Issued to
_____________________________________________________________________________________
2003-08 Potential Flooding Through 06/25/2003 All holders of operating licenses
Unsealed Concrete Floor or construction permits for
Cracks nuclear power reactors.
2003-07 Water in the Vent Header/vent 06/24/2003 All holders of operating licenses
Line Spherical Junctions for boiling water reactors (BWRs)
with a Mark I containment.
2003-06 Failure of Safety-related 06/19/2003 All holders of operating licenses
Linestarter Relays at San or construction permits for
Onofre Nuclear Generating nuclear power reactors, except
Station those that have permanently
ceased operations and have
certified that fuel has been
permanently removed from the
reactor.
2003-05 Failure to Detect Freespan 06/05/2003 All holders of operating licenses
Cracks in PWR Steam or construction permits for
Generator Tubes pressurized-water reactors
(PWRs).
2002-15, Sup 1 Potential Hydrogen 05/06/2003 All holders of operating licenses
Combustion Events in BWR for light water reactors, except
Piping those who have permanently
ceased operations and have
certified that fuel has been
permanently removed from the
reactor.
Note: NRC generic communications may be received in electronic format shortly after they are issued by
subscribing to the NRC listserver as follows:
To subscribe send an e-mail to <listproc@nrc.gov >, no subject, and the following command in the
message portion:
subscribe gc-nrr firstname lastname
______________________________________________________________________________________
OL = Operating License
CP = Construction Permit