FDA.reportPublic FDA data

MAUDE MDR 4853036

MDR report key
4853036
Report number
3008089360-2015-00002
Event key
0
Event type
3
Date of event
2015-04-28
Date received
2015-05-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
0

Manufacturer Contact#

Contact
SHIVA ARDAKANI
Address
7060 KOLL CENTER PARKWAY SUITE 300 PLEASANTON CA 94566 US
Phone
925-925-9259
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CHOCOLATE PTA BALLOON CATHETERPERCUTANEOUS CATHETERTRIREME MEDICAL LLCLITCB14-135-40040CB14-135-40040F14-725007R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-05-2701. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT, THE DEVICE WAS PREPPED AND INSERTED PER THE IFU THRU A 7F SHEATH AFTER THE PHYSICIAN HAD TREATED THE VESSEL WITH ARTHRECTOMY FOR INSTENT RESTENOSIS (ISR) AT 3 LESION SITES THAT WERE PREVIOUSLY STENTED WITH SUPERA FIRST AND THEN VIABAHNS. THE PHYSICIAN PASSED THE 4X40 CHOCOLATE OVER A .014 WIRE TO THE FIRST LESION AND INFLATED TO NOMINAL. HE THEN WITHDREW THE PTA TO THE SECOND PROXIMAL LESION IN THE MID SUPERFICIAL FEMORAL ARTERY AND INFLATED TO NOMINAL. HE TRIED TO WITHDRAW PROXIMAL AND MET RESISTANCE SO HE INFLATED AGAIN AT THAT SITE. AFTER INFLATION HE STILL MET RESISTANCE BUT FELT A RELEASE AND THE PTA WAS WITHDRAWN TO THE MOST PROXIMAL LESION. HE TREATED THAT SITE AND WITHDREW THE PTA. UPON REMOVAL OF THE CHOCOLATE FROM THE SHEATH THEY NOTICED THAT THE NITINOL CAGE WAS NO LONGER ON THE PTA. THE PHYSICIAN WAS ABLE TO LOCATE THE CAGE AT THAT SITE OF THE SECOND LESION WHERE HE HAD PREVIOUSLY MET RESISTANCE AT THE END OF A VIABAHN. HE TRIED SEVERAL TIMES TO SNARE, BALLOON AND WIRE PAST THE CAGE IN AN ATTEMPT TO REMOVE IT BUT WAS UNSUCCESSFUL.

N

Patient 1

RELEVANT ANGIOGRAMS WERE REQUESTED BUT HAVE NOT YET ARRIVED. THE INTERNAL INVESTIGATION IS ON-GOING. A FOLLOW-UP MDR WILL BE FILED AFTER RECEIPT AND REVIEW OF THE ANGIOGRAMS AND COMPLETION OF THE INTERNAL INVESTIGATION.