TRACER HYBRID WIRE GUIDE
Report
- Report Number
- 1037905-2010-00426
- Event Type
- Malfunction
- Date Received
- August 25, 2010
- Date of Event
- July 26, 2010
- Report Date
- July 26, 2010
- Manufacturer
- COOK ENDOSCOPY
- Product Code
- KOG
- PMA / PMN Number
- K910497
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- UNKNOWN
Narratives
EVALUATION: OUR EVAL OF THE RETURNED DEVICE CONFIRMED THE REPORT OF DAMAGED WIRE GUIDE COATING. THE OUTER COATING OF THE WIRE GUIDE HAS SEPARATED NEAR THE DISTAL END, BUT THE DAMAGED SECTION OF COATING DID NOT DETACH FROM THE INNER CORE OF THE WIRE GUIDE. THIS DAMAGED AREA IS LOCATED APPROX 9CM FROM THE DISTAL END OF THE WIRE GUIDE AND EXPOSES APPROX 10CM OF THE INNER CORE WIRE. NO SECTION OF THE WIRE GUIDE COATING IS MISSING. AFTER A REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED, WE CAN REPORT NO DISCREPANCIES OR ANOMALIES WERE OBSERVED. WE WERE UNABLE TO CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE NONE OF THE PRODUCT FROM THIS LOT REMAINED IN FINISHED GOODS INVENTORY. A REVIEW OF THE 12 MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. CONCLUSIONS: A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LAB ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. IF THE WIRE GUIDE RECEIVES EXCESSIVE PRESSURE, PERHAPS IN RESPONSE TO RESISTANCE DUE TO A SEVERE STRICTURE, THIS COULD HAVE CONTRIBUTED TO WIRE GUIDE COATING DAMAGE. THE INSTRUCTIONS ADVISE THE USER THAT THE WIRE GUIDE SHOULD BE KEPT WET FOR BEST RESULTS. THE INSTRUCTIONS FOR USE DESCRIBE THE APPROPRIATE FLUSHING TECHNIQUES FOR USE OF THIS COATED WIRE GUIDE. THESE TECHNIQUES DESCRIBED INCLUDE FLUSHING THE WIRE GUIDE HOLDER WITH 30CC OF STERILE WATER PRIOR TO REMOVING THE WIRE GUIDE FROM THE HOLDER, FLUSHING THE ENDOSCOPE ACCESSORY CHANNEL AND/OR LUMEN OF ACCESSORY DEVICE WITH STERILE WATER BEFORE WIRE GUIDE INSERTION. IF THESE FLUSHING TECHNIQUES ARE NOT FOLLOWED OR INADEQUATE FLUSHING OCCURS, THIS CAN CONTRIBUTE TO WIRE GUIDE COATING DAMAGE. PRIOR TO DISTRIBUTION, ALL TRACER HYBRID WIRE GUIDES ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: THE COMPLAINT RISK PRIORITY NUMBER (CRPN) FOR THIS TYPE OF OCCURRENCE HAS BEEN CALCULATED BASED ON THE RATE OF OCCURRENCE AND SEVERITY OF THE OUTCOME. BASED ON THIS ACTIVITY, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.
DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), AN EXTRACTION BALLOON CATHETER WAS ADVANCED OVER THE TRACER HYBRID WIRE GUIDE. AS THE DISTAL END OF THE CATHETER EXITED THE ENDOSCOPE, THE COATING OF THE WIRE GUIDE BEGAN TO PEEL NEAR THE TIP. THE COATING BECAME LODGED INSIDE THE CATHETER CAUSING AN INABILITY TO ADVANCE THE CATHETER OVER THE WIRE GUIDE. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PT. NO ADD'L MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRACER HYBRID WIRE GUIDE | KOG, ENDOSCOPE AND/OR ACCESSORIES | KOG | COOK ENDOSCOPY | W2858704 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | COOK ENDOSCOPY FS-QEB-A EXTRACTION BALLOON| OLYMPUS TJF-160F ENDOSCOPE |