FDA.reportPublic FDA data

MAUDE MDR 5137555

MDR report key
5137555
Report number
1651662-2004-00006
Event key
0
Event type
3
Date of event
2003-10-20
Date received
2004-03-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
DENISE VINMANS
Address
26531 YNEZ ROAD TEMCULA CA 92591 US
Phone
909-909-9099
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GALILEO INTRAVASCULAR RADIOTHERAPY CARTRIDGE, SOURCE WIRERADIATION SYSTEM CARTRIDGEGUIDANT VASCULAR INTERVENTIONMOU1008112-0CNANAY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12004-03-190

Event Narratives#

N

Patient 1

METHOD: THE EVENT LOG FOR THIS DEVICE WAS EVALUATED NOT THE DEVICE ITSELF. (B)(4). DURING PROCESSING OF THIS COMPLAINT, QUALITY ASSURANCE ATTEMPTED TO OBTAIN COMPLETE EVENT INFORMATION AND PATIENT STATUS FROM THE HOSPITAL, FIELD CONTACT OR DISTRIBUTOR. EVALUATION SUMMARY: DR. WILLIAMS FAXED A DRAWING DEMONSTRATING THE PARTICULAR TREATMENT HE HAD QUESTIONS ABOUT. THE SUMMARY OF HIS THREE QUESTIONS WERE WHAT DOSE WAS GIVEN IN THE OVERLAPPED REGION USING A RLD OF 3.2 MM (USING A 3.0 MM CATHETER), WHAT DOSE WAS GIVEN IN THE 5 MM TRANSITIONAL SEGMENT SHOWN IN THE DRAWING AND WHAT DOSE WAS GIVEN TO SEGMENT C AS SHOWN IN THE DRAWING. IN WORKING WITH GUIDANT CONSULTANT PHYSICIST, THEY RESOLVED THAT THE DOSE GIVEN IN THE OVERLAPPED REGION WAS 280 CGY. THE DOSE IN THE 5 MM TRANSITIONAL SEGMENT STARTS AT 2080 CGY AND DROPS VERY QUICKLY TO 1364 CGY. LASTLY, THE DOSE FOR SEGMENT C WAS DETERMINED TO BE 1364 CGY. SUBSEQUENTLY, THE SITE PHYSICIST, (B)(6), CONTACTED ANOTHER GUIDANCE CONSULTANT ABOUT THIS CASE. THE PHYSICIST RECREATED THE TREATMENT AND FILMED IT. THE RESULTS OF THIS RECREATION RESULTED IN A DIFFERENT DOSE CALCULATION ESTIMATE FROM THE ORIGINAL CALCULATIONS. A GUIDANCE RADIATION SAFETY OFFICER (RSO) AND CONSULTANT PHYSICIST CONSULTED WITH THE SITE TO RECONCILE THE CALCULATIONS. IT WAS DETERMINED THROUGH ADDITIONAL RECREATION AND THE USAGE OF THE RETURNED CARTRIDGE EVENT LOG DATA THAT THE DOSE IN THE OVERLAP REGION WAS ABOUT 2700-2800 CGY. THE DOSE IN THE NON-OVERLAP REGION WAS ABOUT 2000 CGY DISTALLY AND ABOUT 1500 CGY PROXIMALLY. PREVIOUS ESTIMATED HAD CALCULATED 2000 AND 1364 CGY RESPECTIVELY. GUIDANT CONTACTED THE SITE AND BOTH THE RADIATION ONCOLOGIST AND THE PHYSICIST DO NOT BELIEVE THAT THE ABOVE DOSES WERE INJURIOUS TO THE PATIENT. THE EVENT LOG DATA WAS REVIEWED FOR THIS TREATMENT AND THE RSO CALCULATED THE DOSE DELIVERED IN THE OVERLAP REGION AS 2775 CGY. THE DOSE IN THE NON-OVERLAP REGION WAS 2000 CGY DELIVERED DISTALLY AND 1364 CGY DELIVERED PROXIMALLY. THE DELIVERED DOSES OUTSIDE THE PRESCRIBED RANGE WERE DUE TO THE USER PERFORMING A COMPLETE TREATMENT IN ADDITION TO A PARTIAL TREATMENT FOR THE SAME PATIENT IN THE SAME LESION, WHICH RESULTED IN AN OVERLAP. THE SITE WAS INFORMED OF THE DOSAGE CALCULATIONS BASED ON THE EVENT LOG DATA. AN IFU ADDENDUM HAS BEEN RELEASED THAT CONTAINS A WARNING STATEMENT TO REINFORCE THE IMPORTANCE OF PROPERLY RESUMING A TREATMENT, AS SPECIFIED IN THE IFU, AND TO WARN USERS OF THE POTENTIAL CONSEQUENCES OF RADIATION OVERDOSE.

D

Patient 1

THE RADIOLOGIST ONCOLOGIST REQUESTED TO SPEAK WITH A PHYSICIST TO ANSWER QUESTIONS CONCERNING OVERLAP DURING A TREATMENT PERFORMED THIS MORNING (2003). THE TREATMENT CONSISTED OF THE FOLLOWING: A TWO-POSITION TREATMENT WAS PERFORMED, IN WHICH THE SECOND POSITION WAS INTERRUPTED BY THE RADIATION ONCOLOGIST, THEN THE RADIATION ONCOLOGIST REPOSITIONED THE CATHETER AND INITIATED A NEW TWO-POSITION TREATMENT WITH THE FIRST POSITION OVERLAPPING WITH THE SECOND POSITION OF THE FIRST TREATMENT. THIS SECOND TREATMENT WAS COMPLETED SUCCESSFULLY.