OPTA PRO PTA DILATATION CATHETER
Report
- Report Number
- 9610978-2011-00020
- Event Type
- Injury
- Date Received
- January 28, 2011
- Date of Event
- January 12, 2011
- Report Date
- January 14, 2011
- Manufacturer
- CORDIS EUROPA, N.V.
- Product Code
- LIT
- PMA / PMN Number
- K032737
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
THE INFORMATION RECEIVED INDICATED THAT A SUB-INTIMAL ANGIOPLASTY OF THE SUPERFICIAL FEMORAL ARTERY (SFA) WAS PERFORMED. AN OPTA PRO PTA BALLOON BURST ON INFLATION. WHILE ATTEMPTING TO WITHDRAW THE BALLOON IT DID NOT COME OUT OF THE SHEATH AND BECAME STUCK. ADDITIONAL FORCE WAS APPLIED AND A SNAP WAS HEARD, THE BALLOON SEPARATED AND PART OF THE BALLOON WAS LEFT INSIDE THE PATIENT. IT WAS THOUGHT THAT THE BALLOON BURST CIRCUMFERENTIALLY. THE SEPARATED PIECE REMAINS IN THE SFA LESION. THE PATIENT IS REPORTED AS FINE AND IS BEING MONITORED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15250172 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION. HOWEVER, NO ADDITIONAL INFORMATION REGARDING PATIENT, LESION OR PROCEDURAL CHARACTERISTICS REGARDING THIS EVENT HAS BEEN PROVIDED. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.
THE INFORMATION RECEIVED INDICATED THAT A SUB-INTIMAL ANGIOPLASTY OF THE SUPERFICIAL FEMORAL ARTERY (SFA) WAS PERFORMED. AN OPTA PRO PTA BALLOON BURST ON INFLATION. WHILE ATTEMPTING TO WITHDRAW THE BALLOON IT DID NOT COME OUT OF THE SHEATH AND BECAME STUCK. ADDITIONAL FORCE WAS APPLIED AND A SNAP WAS HEARD, THE BALLOON SEPARATED AND PART OF THE BALLOON WAS LEFT INSIDE THE PATIENT. IT WAS THOUGHT THAT THE BALLOON BURST CIRCUMFERENTIALLY. THE SEPARATED PIECE REMAINS IN THE SFA LESION. THE PATIENT IS REPORTED AS FINE AND IS BEING MONITORED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION. HOWEVER, NO ADDITIONAL INFORMATION REGARDING PATIENT, LESION OR PROCEDURAL CHARACTERISTICS REGARDING THIS EVENT HAS BEEN PROVIDED. A NON STERILE OPTA PRO 5.0MMX4CM, 80CM WAS RECEIVED COILED AND INSIDE A BAG. THE BALLOON WAS DETACHED AT 1CM FROM THE PROXIMAL SEAL AND IT WAS NOT INCLUDED. THE BALLOON APPEARS AS IF IT HAD A RADIAL BURST. THE INNER BODY WAS NOT INCLUDED. BALLOON PROFILE COULD NOT BE PERFORMED. NO OTHER ANOMALY WAS NOTED IN THE RETURNED DEVICE. THE LEAKAGE FUNCTIONAL TEST FOR THE BALLOON PER (B)(6) COULD NOT BE PERFORMED DUE TO DEVICE CONDITIONS. A SCANNING ELECTRON MICROSCOPE WAS DONE TO THE BALLOON AND THE RESULTS SHOWED THAT THE BALLOON EXTERNAL SURFACE SHOWED EVIDENCE OF SPLIT CONDITION AND ABRASIONS. THE BALLOON INTERNAL SURFACE EXHIBITED NO EVIDENCE OF DAMAGE. THE EXACT CAUSE OF THE OBSERVED FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. THE PROXIMAL SEAL MEASURE WAS DONE AND THE OBTAINED VALUE WAS 1.821MM, THE PROXIMAL SEAL OD SPECIFICATION IS 5F </= 1.88MM, WHICH IS WITHIN SPEC. (B)(4). IT WAS USED A MICROMETER LASER ID (B)(4) WITH CALIBRATION DUE DATE (B)(6) 2011. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE REPORTED BALLOON BURST, BALLOON SEPARATED AND PTA WITHDRAWAL DIFFICULTY WERE CONFIRMED; HOWEVER, THE EXACT CAUSE OF THE BALLOON BURST COULD NOT BE CONCLUSIVELY DETERMINED. THE BALLOON SEPARATED AND PTA WITHDRAWAL DIFFICULTY FAILURES CAN BE ATTRIBUTED WHEN THE BALLOON GOT STUCK IN THE SHEATH. NEITHER THE PRODUCT ANALYSIS NOR THE MANUFACTURING RECORDS REVIEW SUGGESTS THAT THE FAILURES EXPERIENCED BY THE COSTUMER COULD BE RELATED TO THE MANUFACTURING PROCESS. CONTROLS ARE IN PLACE TO DETECT DEFECTIVE BALLOONS BEFORE LEAVING THE FACILITY. ACTION TAKEN: NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN; GIVEN THAT, THE REPORTED FAILURE DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. THE BALLOON SHOWED EVIDENCE OF ABRASIONS ON THE OUTER SURFACE THAT WOULD IMPLY THAT VESSEL CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. THE ADDITIONAL PHYSICAL FORCE USED WHILE TRYING TO REMOVE THE BALLOON THROUGH THE SHEATH IS THE LIKELY CAUSE OF THE SEPARATION. VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.
SEVERAL ATTEMPTS HAVE BEEN MADE TO REQUEST THE PRODUCT RETURN, BUT HAVE BEEN UNSUCCESSFUL. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15250172 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4) UNIT WAS REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNIT WAS PROPERLY SEGREGATED AND DISCARDED. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. (B)(4) WAS GENERATED IN ORDER TO STOP THE PRODUCT BY 2 YIELD EXCURSIONS, POINT OUT OF CONTROL (LCL ON OVERALL YIELD)(IX), EXCEEDS THE VALUE OF PPM'S IN THE DEFECT CLASS I (HUB DAMAGED. THE PRODUCT WAS ACCEPTED DUE THAT MET THE QUALITY REQUIREMENTS THEREFORE THE PTHS WAS CLOSED. CA OPRO SUBASSEMBLY LOTS 15244887 AND 15232835 WERE REVIEWED AND (B)(4) UNITS WERE REJECTED DURING THE ASSEMBLY OF THESE LOTS. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. IT WAS OBSERVED DURING REVIEW THAT NO NONCONFORMANCE RECORDS WERE ISSUED FOR THESE LOTS. NO OTHER INCIDENTS WERE NOTED THAT COULD BE POTENTIALLY RELATED TO THE COMPLAINT REPORTED. BALLOON ASSY OPRO SUBASSEMBLY LOTS 15233688, 15231764, 15209520 AND 15209513 WERE REVIEWED AND NO UNITS WERE REJECTED DURING THE ASSEMBLY OF THESE LOTS. IT WAS OBSERVED DURING REVIEW THAT NO NONCONFORMANCE RECORDS WERE ISSUED FOR THESE LOTS. NO OTHER INCIDENTS WERE NOTED THAT COULD BE POTENTIALLY RELATED TO THE COMPLAINT REPORTED. INFLATION/DEFLATION AND BURST TEST RESULTS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING MANUFACTURING PROCESS OF THESE LOTS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.
THE PRODUCT IS AVAILABLE FOR EVALUATION, BUT HAS NOT BEEN RETURNED YET. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.
THE INFORMATION RECEIVED INDICATED THAT A SUB-INTIMAL ANGIOPLASTY OF THE SUPERFICIAL FEMORAL ARTERY (SFA) WAS PERFORMED. USED AN OPTA PRO BALLOON AND ON INFLATION THE BALLOON BURST. TRIED TO WITHDRAW THE BALLOON CATHETER, TO SEE IF THERE WAS ANY DAMAGE. BUT THE BALLOON DID NOT COME OUT OF SHEATH AND WAS STUCK. TRIED TO PUT A WIRE THROUGH TO EXCHANGE AND PULL THE SHEATH OUT BUT RESISTANCE WAS FELT. APPLIED MORE FORCE TO GET THE BALLOON OUT AND HEARD A SNAP AND PART OF THE BALLOON WAS LEFT INSIDE THE PATIENT. IT SEEMS AS THOUGH THE BALLOON BURST CIRCUMFERENTIALLY. THEY HAVE MANAGED TO GET THE BALLOON ARTEFACT INSIDE THE SFA LESION AND IT REMAINS THERE. THE PATIENT IS FINE AND IS BEING MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OPTA PRO PTA DILATATION CATHETER | PTA CATHETERS (LIT) | LIT | CORDIS EUROPA, N.V. | NA | 15250172 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |