FDA.reportPublic FDA data

MAUDE MDR 3701697

MDR report key
3701697
Report number
3008089360-2014-00001
Event key
0
Event type
3
Date of event
2014-01-22
Date received
2014-02-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
SHIVA ARDAKANI
Address
7060 KOLL CENTER PARKWAY SUITE 300 PLEASANTON CA 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 CATHETERLITCB18-120-60080CB18-120-60080FE130924002Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-02-2101. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT A 6.0X80 CHOCOLATE BALLOON WAS USED IN THE RIGHT EXTERNAL ILIAC TO COMMON FEMORAL IN STENT, IN A VERY COMPLEX CASE WITH A PATIENT THAT HAD FOUR EXISTING STENTS INCLUDING ICAST STENT IN THE RIGHT EXTERNAL AND COMMON ILIAC. THE BALLOON WAS INFLATED BALLOON AT 12 ATM FOR TWO MINUTES. INFLATION WENT WELL BUT IN PULLING BACK, RESISTANCE WAS FELT AND THEY COULD NOT SEE BECAUSE OF THE MULTIPLE EXISTING STENTS. THOUGH THE BALLOON WAS RETRIEVED, THE CAGE CAME COMPLETELY FREE OF THE BALLOON AND WAS NOT ABLE TO BE RETRIEVED FROM PATIENT. WITH THE CAGE REMAINING IN THE PATIENT A PROTEGE CV3 STENT WAS DEPLOYED AND WAS POST DILATED WITH A BOSTON SCIENTIFIC MUSTANG BALLOON CATHETER. ACCORDING TO THE DOCTOR THE FINAL RESULT LOOKED EXCELLENT AND THERE WERE NO CLINICAL IMPLICATIONS.

N

Patient 1

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