PUSHING CATHETER
Report
- Report Number
- 3001845648-2023-00720
- Event Type
- Malfunction
- Date Received
- September 15, 2023
- Date of Event
- July 25, 2023
- Report Date
- March 1, 2024
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PMA/510(K) # K172044 AND K172057. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) # K172044 AND K172057. DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. THIS COMPLAINT IS RELATED TO (B)(4) WHICH WAS OPENED TO INVESTIGATE A KINK IN THE TTSO STENT. THIS ADDITIONAL FILE WAS OPENED TO INVESTIGATE THE USER ERROR OF THE INCORRECT SIZED WIREGUIDE (0.025") USED WITH THE PC-7 DEVICE DURING THE SAME PROCEDURE. MANUFACTURING RECORDS: MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. REVIEW HISTORICAL DATA: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE AND LABEL: THE NOTES SECTION OF THE INSTRUCTIONS FOR USE (IFU0130), WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO INSPECT THE DEVICE PRIOR TO USE : "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. (IFU0130) IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD BE ATTRIBUTED TO USER ERROR AND THE USE OF A SMALLER THAN REQUIRED SIZE (0.025 INCH) WIRE GUIDE. IT MAY BE NOTED THE DEVICE LABEL INDICATES A 0.035¿ WIRE GUIDE FOR USE WITH THIS DEVICE AND ALL SIMULATED USE TESTING TO DATE HAS BEEN COMPLETED USING A 0.035¿ WIRE GUIDE. AS PER INFORMATION PROVIDED A 0.025" WIRE GUIDE WAS USED WITH THE PUSHING CATHETER. CAPA 387756 HAS BEEN INITIATED FROM COMPLAINTS RELATED TO USER ERROR IN PRACTICE A 0.025¿ WIRE GUIDE IS BEING USED. FROM THE ADDITIONAL INFORMATION PROVIDED THERE WAS ALSO ADDITIONAL USER ERROR NOTED. THE WIRE GUIDE WAS NOT INSPECTED PRIOR TO USE NOR WAS THE DEVICE AT THE CENTRE OF THE COMPLAINT INSPECTED FOR DAMAGE PRIOR TO USE. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/CORRECTION: CAPA 387756 HAS BEEN INITIATED FROM COMPLAINTS RELATED TO USER ERROR IN PRACTICE A 0.025¿ WIRE GUIDE IS BEING USED. SUMMARY OF INVESTIGATION: ACCORDING TO THE CUSTOMER, INCORRECT SIZE WIRE GUIDE USED WITH PC-7 CONFIRMED QUANTITY OF 1 DEVICE , CONFIRMED USED. ACCORDING TO THE INITIAL REPORT, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION FINDINGS CONCLUDE THAT A DEFINITIVE ROOT CAUSE COULD BE ATTRIBUTED TO USER ERROR AND THE USE OF A SMALLER THAN REQUIRED SIZE (0.025 INCH) WIRE GUIDE. IT MAY BE NOTED THE DEVICE LABEL INDICATES A 0.035¿ WIRE GUIDE FOR USE WITH THIS DEVICE AND ALL SIMULATED USE TESTING TO DATE HAS BEEN COMPLETED USING A 0.035¿ WIRE GUIDE. AS PER INFORMATION PROVIDED A 0.025" WIRE GUIDE WAS USED WITH THE PUSHING CATHETER. CAPA 387756 HAS BEEN INITIATED FROM COMPLAINTS RELATED TO USER ERROR IN PRACTICE A 0.025¿ WIRE GUIDE IS BEING USED. FROM THE ADDITIONAL INFORMATION PROVIDED THERE WAS ALSO ADDITIONAL USER ERROR NOTED. THE WIRE GUIDE WAS NOT INSPECTED PRIOR TO USE NOR WAS THE DEVICE AT THE CENTRE OF THE COMPLAINT INSPECTED FOR DAMAGE PRIOR TO USE.
WHEN DR. (B)(6) TRIED TO INSERT CLSO INTO THE STRICTURE, THE STENT WAS KINK. SO DR.(B)(6) USED ANOTHER CLSO.. ((B)(4)) AS PER PATIENT/EVENT INFO ¿ NOTES: 12. PLEASE INDICATE ANY OTHER ENDOSCOPIC ACCESSORIES (IF ANY) THAT CAME INTO CONTACT WITH THE STENT OR INTRODUCTION SYSTEM DURING THE PROCEDURE. COOK ACROBAT2 0.025", PC-7 ((B)(4)). DID ANY SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT BODY? NO. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURE(S)? NO. WERE THERE ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE ADVERSE EFFECT(S)? NO. 1. PLEASE INDICATE WHERE THE DEVICE WAS STORED PRIOR TO USE. PLASTIC STENT STORAGE CABINET. 2. WHAT IS THE REORDER NUMBER, OUTER DIAMETER AND LENGTH OF THE WIRE GUIDE THAT WAS USED WITH THIS DEVICE IN THIS PROCEDURE? COOK ACROBAT2, 0.025", 450CM. 3. WERE PREVIOUS PROCEDURES I.E. SPHINCTEROTOMY ETC. CARRIED OUT PRIOR TO PLACING THE DEVICE OVER THE PARTICULAR WIRE GUIDE? IF YES PLEASE INDICATE THE PROCEDURE PERFORMED. DR.(B)(6) DID SPHINCTEROTOMY USING THE AUTOTOME. 4. WAS THE WIRE GUIDE INSPECTED FOR DAMAGE PRIOR TO USE?* NO. 5. WAS THE DEVICE AT THE CENTRE OF THE COMPLAINT INSPECTED FOR DAMAGE PRIOR TO USE? NO. 6. DID THE PATIENT INVOLVED EXHIBIT ALTERED ANATOMY OR TORTUOUS ANATOMY? NO. 7. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED?* THEY USED ANOTHER CLSO. FOR COMPLAINTS OCCURRING DURING USE (ONCE IN CONTACT WITH ENDOSCOPE) ALSO ASK: 1. HAD A SPHINCTEROTOMY BEEN PERFORMED PRIOR TO THIS OCCURRENCE? YES. 2. WHAT IS THE ENDOSCOPE MANUFACTURER, THE MODEL NUMBER AND WORKING CHANNEL SIZE THAT WAS USED FOR THE PROCEDURE? OLUMPUS TJF-260V. 3. DOES YOUR MEDICAL FACILITY HAVE A SERVICE/MAINTENANCE SCHEDULE ASSOCIATED WITH ITS ENDOSCOPES? YES 4. PLEASE INDICATE THE LOCATION IN THE BODY WHERE THE STENT DEVICE WAS TO BE PLACED. I.E. BILIARY DUCT, PANCREATIC DUCT, OTHER. CBD 5. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE TO THE TARGET LOCATION?* A LITTLE 6. WAS THE STRICTURE DILATED PRIOR TO PLACING THE DEVICE?* IF SO, PLEASE INDICATE WHAT DEVICE(S) WERE USED. NO 7. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE INTRODUCTION SYSTEM IN PLACE TO THE TARGET LOCATION?* A LITTLE 8. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE STENT THROUGH THE OBSTRUCTED AREA?* N/A (MARK N/A IF DEVICE WAS NOT USED ON ANY PATIENT) AFTER PLACEMENT, WAS STENT POSITION VERIFIED? IF YES, PLEASE DESCRIBE HOW. NO 9. PLEASE ESTIMATE/INDICATE THE AMOUNT OF TIME THE STENT WAS IN PLACE DWELLING PRIOR TO THIS OCCURRENCE. N/A 10. DID ANY SECTION OF THE DEVICE DETACH INSIDE THE ENDOSCOPE OR PATIENT? NO 11. IF THE DEVICE BROKE UPON REMOVAL, PLEASE INDICATE WHAT REMOVAL TOOL(S) WERE USED (MANUFACTURER). NO 12. PLEASE INDICATE ANY OTHER ENDOSCOPIC ACCESSORIES (IF ANY) THAT CAME INTO CONTACT WITH THE STENT OR INTRODUCTION SYSTEM DURING THE PROCEDURE. COOK ACROBAT2 0.025", PC-7. 13. WERE ANY MODIFICATIONS MADE TO THE COMPLAINT DEVICE OR ACCESSORIES USED WITH THE DEVICE IN THIS PROCEDURE? ¿ FOR EXAMPLE GUIDING CATHETER SHORTENED. IF SO PLEASE INDICATE THE MODIFICATIONS AND WHY THEY WERE NECESSARY. NO * NOT APPLICABLE IF PROBLEM OCCURRED AT REMOVAL.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 01-MAR-2024.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 295672 | PUSHING CATHETER | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |