MAUDE MDR 906744

MDR report key
906744
Report number
1062385-2004-00006
Event key
0
Event type
3
Date of event
2004-09-17
Date received
2004-10-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
DREW GREEN, VP
Address
4350 INTERNATIONAL BLVD. NORCROSS GA 30093 US
Phone
770-770-7707
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
15F BETA-RAIL DELIVERY CATHETERCATHETERNOVOSTE CORPMOUP02578ABR-0346737827NRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12004-10-0701. O

Event Narratives#

D

Patient 1

THE SITE REPORTED THAT DURING TREATMENT OF IN-STENT RESTENOSIS OF THE DISTAL ANTERIOR DESCENDING CORONARY ARTERY, AFTER THE AREA WAS TREATED WITH MULTIPLE ANGIOPLASTIES WITH A 3.0MM BALLOON, A 60MM RADIOACTIVE SOURCE TRAIN WAS SELECTED. AFTER SENDING SOURCE TRAIN, IT WAS RECOGNIZED THAT THE SOURCE TRAIN WAS NOT LONG ENOUGH TO TREAT THE ENTIRE INJURY AREA. THE CATHETER WAS PULLED BACK IN ORDER TO TREAT THE SECOND SEGMENT. THE SOURCE TRAIN WAS SENT AGAIN, THERE WAS SOME DIFFICULTY GETTING THE SOURCE TRAIN TO THE DISTAL TIP OF THE CATHETER, BUT THE SOURCE TRAIN DID REACH THE DISTAL TIP. THE PROXIMAL SEGMENT WAS TREATED. AFTER TREATMENT WAS COMPLETED, FILMS WERE REVIEWED TO DETERMINE WHY THE RADIOACTIVE SOURCE TRAIN WAS NOT LONG ENOUGH TO TREAT THE ENTIRE INJURY AREA. IT WAS DETERMINED THAT UPON INITIAL DELIVERY OF THE RADIOACTIVE SOURCE TRAIN, THE SOURCE TRAIN STOPPED SHORT OF THE DISTAL END OF THE DELIVERY CATHETER BY 25 - 30MM. THE PROXIMAL MARKER WAS NOT CLEARLY VISIBLE BECAUSE IT RAN POSTERIORLY BEHIND THE GUIDE CATHETER AND OTHER RADIOACTIVE SEEDS. THE DISTAL MARKER WAS RECOGNIZED AS THE PROXIMAL MARKER BECAUSE OF WHERE IT WAS IN RELATIONSHIP TO THE DISTAL TIP OF THE CATHETER, THUS THE DISTAL SEGMENT OF THE CATHETER NEVER REC'D THE PRESCRIBED RADIATION. BECAUSE THE SOURCE TRAIN NEVER REACHED THE DISTAL ENDO F THE CATHETER ON THE FIRST DWELL, AND A SECOND DWELL WAS USED TO TREAT THE PROXIMAL SEGMENT, A 35-40MM SEGMENT REC'D TWICE THE PRESCRIBED AMOUNT OF RADIATION.