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During a medical procedure on a patient, t … During a medical procedure on a patient, two individual coronary artery locations were being irradiated with Sr-90 (2.05 GBq, serial # ZA-494. The device being used, Novoste Intravascular Brachytherapy Beta-Cath System Transfer (S/N# 90556), hereinafter called "Device", failed to work properly. </br>The licensee noticed the source did not retract into the Device. At this point the licensee pulled the entire catheter out of the patient, and within one minute was able to return the sources safely into the Device. It was assumed the problem was with the catheter and it's connection to the Device. </br>The licensee continued to the next location on the patient. Upon attempting to return the source, the licensee noticed the sources were not moving from the patient. Within 5-10 seconds, the licensee pulled the entire catheter from the patient, and then placed the entire system into the "bailout" box for proper shielding from beta radiation. The next day the licensee called Novoste and explained the events. Novoste determined it was a faulty Device and sent the licensee a replacement. </br>On May 19, 2005 the replacement arrived and the faulty device was sent back to the company.aulty device was sent back to the company. +
19:30:00, 17 April 2005 +
41,720 +
15:57:00, 19 May 2005 +
19:30:00, 17 April 2005 +
During a medical procedure on a patient, t … During a medical procedure on a patient, two individual coronary artery locations were being irradiated with Sr-90 (2.05 GBq, serial # ZA-494. The device being used, Novoste Intravascular Brachytherapy Beta-Cath System Transfer (S/N# 90556), hereinafter called "Device", failed to work properly. </br>The licensee noticed the source did not retract into the Device. At this point the licensee pulled the entire catheter out of the patient, and within one minute was able to return the sources safely into the Device. It was assumed the problem was with the catheter and it's connection to the Device. </br>The licensee continued to the next location on the patient. Upon attempting to return the source, the licensee noticed the sources were not moving from the patient. Within 5-10 seconds, the licensee pulled the entire catheter from the patient, and then placed the entire system into the "bailout" box for proper shielding from beta radiation. The next day the licensee called Novoste and explained the events. Novoste determined it was a faulty Device and sent the licensee a replacement. </br>On May 19, 2005 the replacement arrived and the faulty device was sent back to the company.aulty device was sent back to the company. +
Has query"Has query" is a predefined property that represents meta information (in form of a <a rel="nofollow" class="external text" href="https://www.semantic-mediawiki.org/wiki/Subobject">subobject</a>) about individual queries and is provided by <a rel="nofollow" class="external text" href="https://www.semantic-mediawiki.org/wiki/Help:Special_properties">Semantic MediaWiki</a>.
00:00:00, 19 May 2005 +
37-07722-04 +
Modification date"Modification date" is a predefined property that corresponds to the date of the last modification of a subject and is provided by <a rel="nofollow" class="external text" href="https://www.semantic-mediawiki.org/wiki/Help:Special_properties">Semantic MediaWiki</a>.
02:20:57, 2 March 2018 +
15:57:00, 19 May 2005 +
31.852 d (764.45 hours, 4.55 weeks, 1.047 months) +
19:30:00, 17 April 2005 +
Part 21 Report - Malfunction of Novoste Intravascular Brachytherapy Beta-Cath System Transfer Device +
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