FDA.reportPublic FDA data

MAUDE MDR 5943392

MDR report key
5943392
Report number
3008089360-2016-00001
Event key
0
Event type
3
Date of event
2016-03-31
Date received
2016-09-12
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
SHIVA ARDAKANI
Address
7060 KOLL CENTER PARKWAY 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 CATHETER, 014" 150 CMPTA BALLOON CATHETERTRIREME MEDICAL LLCLITCF1415030120 OTWF1410001Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-09-1201. H

Event Narratives#

N

Patient 1

INSPECTION AND LOT HISTORY RECORDS FOR LOT # F141001001 AND THE SUBASSEMBLY USED IN ITS MANUFACTURE WERE REVIEWED. NO OUT OF SPECFICATION FINDINGS WERE OBSERVED.RETURN OF THE DEVICE WAS REQUESTED AND RETURNED. IT IS CLEAR THAT THERE IS A STENT ATTACHED TO THE OUTSDIE OF THE CHOCOLATE BALLOON CATHETER CS.

D

Patient 1

PHYSICIAN WAS PERFORMING ANGIOPLASTY IN PATIENT'S RIGHT POSTERIAL TIBIAL ARTERY. AFTER 8 INFLATIONS AND DEFLATIONS ALONG POSTERIAL TIBIAL ARTERY, PHYSICIAN ATTEMPTED TO WITHDRAW THE CHOCOLATE BALLOON THROUGH A 5FR TERUMO DESTINATION SHEATH THAT WAS FROM A CONTRALATERAL APPROACH. BALLOON WAS OVER A 014 COMMAND WIRE. THE BALLOON WAS WITHDRAWN ABOUT HALFWAY INTO SHEATH WHEN IT GOT HUNG-UP ON THE EDGE OF THE SHEATH AND COULDN'T BE TOTALLY WITHDRAWN THROUGH SHEATH. THE SHEATH AND BALLOON HAD TO BE WITHDRAWN FROM PATIENT AS A SINGLE UNIT WHICH WAS SUCCESSFUL. BEFORE DOING THIS THE PHYSICIAN TRIED TO CAPTURE THE ENTIRE SYSTEM WITH 7FR COOK SHEATH BUT WAS UNSUCCESSFUL .PHYSICIAN COMMENTED THAT MOST LIKELY CAUSE WAS THE NITINOL CAGE AROUND THE BALLOON GOT CAUGHT ON DISTAL EDGE OF THE SHEATH BECAUSE OF HIGH NUMBER OF INFLATIONS AND DEFLATIONS AND MAY NOT HAVE BEEN DEFLATED WHEN TRIED TO WITHDRAW THE BALLOON. WHEN THE CHOCOLATE PTA CATHETER WAS RETURNED TO TRIREME MEDICAL, IT WAS IDENTIFIED THAT A STENT IS ATTACHED TO THE CONSTRAINING STRUCTURE (CS).