PNO-IV-99-001, on 990107,intravascular Radiotherapy Misadministration Occurred.Licensee Reported That During Intravascular Radiotherapy procedure,radioisotope,Re-188, Leaked Out of Container & Into Patient Bloodstream
| ML20206P452 | |
| Person / Time | |
|---|---|
| Issue date: | 01/08/1999 |
| From: | Cain C, Mark Shaffer NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| References | |
| PNO-IV-99-001, PNO-IV-99-1, NUDOCS 9901110416 | |
| Download: ML20206P452 (1) | |
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...6 January 8,1999 PRELIMINARY NOTIFICATION OF EVENT OR UNUSUAL OCCURRENCE PNO-IV-99-001 This preliminary notification constitutes EARLY notice of events of POSSIBLE safety or public interest sipificance. The information is as initially received without verification or evaluation, and is basically all that is known by Region IV staff in Arlington, Texas on this date.
Facility Licensee Emeroency Classification California Licensee Notification of Unusual Event Cedars-Sinal Hospital Alert Los Angeles,Califomia Site Area Emergency General Emergency X Not Applicable
Subject:
INTRAVASCULAR RADIOTHERAPY MISADMINISTRATION On January 7,1999, a representative from Cedars-Sinai Hospital, Los Angeles, California (a State of California licensee) notified the State of Califomia Radiologic Health Branch (CRHB) of a misadministration which occurred at the licensee's facility on January 6,1999.
The licensee reported that during an intravascular radiotherapy procedure, the radioisotope, rhenium-188 (Re-188), leaked out of its container and into the patient's bloodstream.
Re-188, included as part of an investigative new drug (IND), was used by the licensee during an intravascular radiotherapy procedure to prevent arterial restenosis. Approximately 2 millicuries of Re-188, in liquid form, was contained in a plastic balloon-type device and was inflated during an angioplasty procedure. During the procedure, the Re-188 leaked out of the device and was released into the patient's bloodstream.
The licensee is in the process of developing a dose estimate; however, initial estimates indicate that no adverse health affects to the patient will result from the incident.
The State of Califomia was informed of the event by the licensee. The State will conduct an inspection at the licensee's facility after reviewing their written report of the misadministration, which will include dose estimates.
NRC received notification of this occurrence by CRHB at 4:23 p.m. (EST) on January 7, 1999. Region IV has informed OSP and NMSS.
This information has been discussed with the CRHB and is current as of 2:00 p.m. (CST)
January 8,1999.
Contact:
Mark R. Shaffer Charles L. Cain (817)860-8281 (817)860-8186
> 9901110416 990100 PDR 0D a
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