ZIMMON BILIARY STENT SET
Report
- Report Number
- 3001845648-2025-00136
- Event Type
- Malfunction
- Date Received
- March 18, 2025
- Date of Event
- February 21, 2025
- Report Date
- June 13, 2025
- Manufacturer
- COOK MEDICAL IRELAND
- Product Code
- FGE
- UDI-DI
- 10827002213934
- PMA / PMN Number
- K851962
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JP
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
DEVICE EVALUATION (B)(4) UNIT OF ZEBD-7-4 OF LOT NUMBER C2037540 DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON 03 APRIL 2025. ON EVALUATION OF THE DEVICES THE FOLLOWING OBSERVATIONS WERE MADE: VISUAL INSPECTION: STENT RETURNED. KINK OBSERVED ON THE 5TH PORTHOLE ON THE TAPERED END OF PIGTAIL CURL. NO OTHER DAMAGE OBSERVED. FUNCTIONAL INSPECTION: 0.035 INCH WIRE GUIDE DOES NOT PASS THE KINK. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ZEBD DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. MANUFACTURING RECORDS REVIEW: A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. INSTRUCTIONS FOR USE/LABEL: AS PER THE INSTRUCTIONS FOR USE¿S NOTES SECTION (IFU0045), 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". AS PER THE PRECAUTIONS SECTION OF THE INSTRUCTIONS FOR USE (IFU0045), WHICH ACCOMPANIES THIS DEVICE, "REFER TO PACKAGE LABEL FOR MINIMUM CHANNEL SIZE REQUIRED FOR THIS DEVICE." AND "WIRE GUIDE DIAMETER AND INNER LUMEN OF WIRE-GUIDED DEVICE MUST BE COMPATIBLE." THE PRODUCT LABEL STATES THE GUIDE WIRE SIZE FOR USE WITH THIS DEVICE IS 0.035". THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU/LABEL. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF USE ERROR WAS ESTABLISHED. FROM THE INFORMATION AVAILABLE, IT IS KNOWN THAT AN INCORRECT SIZE WIRE GUIDE WAS USED WITH THE DEVICE. THE PRODUCT LABELLING INSTRUCTS THE USER TO USE A 0.035¿ WIRE GUIDE. ALL DESIGN TESTING HAS BEEN COMPLETED USING A 0.035¿ WIRE GUIDE. THEREFORE, USING AN ALTERNATIVE SIZE OF WIRE GUIDE HAS NOT BEEN TESTED AND MAY RESULT IN DAMAGE TO THE STENT. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU AND/OR LABEL. THIS HAS BEEN CONFIRMED IN THE ENGINEER INPUT. SUMMARY: CONFIRMED QTY OF DEVICES: 01 DEVICE USED. COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. INVESTIGATION FINDINGS CONCLUDE A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO USE ERROR - AN INCORRECT SIZE WIRE GUIDE USED WITH THE DEVICE. ACCORDING TO THE INFORMATION PROVIDED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
COMMON BILE DUCT STONE RETRIEVAL WAS PERFORMED USING THE FS-QEB-XL-A VIA A TRANSENDOSCOPIC AND TRANSPAPILLARY APPROACH. AFTER EST, AN EPLBD WAS ADDED AND THE STONE WAS CRUSHED USING A ZEON MEDICAL STONE CRUSHING BASKET. THEN, FS-QEB-XL-A (B)(6) WAS INSERTED THROUGH A GUIDEWIRE (OLYMPUS VISIGLIDE 0.025) ON THE GUIDEWIRE, AND AN ATTEMPT WAS MADE TO INFLATE THE BALLOON IN THE UPPER BILE DUCT, BUT IT HAD RUPTURED. (B)(4) ANOTHER DEVICE OF THE SAME RPN (B)(6) WAS INSERTED AND AN ATTEMPT WAS MADE TO INFLATE IT, BUT IT HAD ALSO RUPTURED IN THE SAME WAY. (B)(4) THEN A TX-15A (LOT UNKNOWN) WAS USED TO EXTRACT STONES. AFTER THAT, TO PLACE A ZEBD-7-4, A GUIDEWIRE WAS INSERTED IN IT, BUT THE PIGTAIL WAS KINKED AND COULD NOT BE INSERTED. ANOTHER DEVICE OF THE SAME RPN (LOT UNKNOWN) WAS USED TO COMPLETE THE PROCEDURE. NO HEALTH HAZARD. 1 FOR ALL COMPLAINTS, ASK: DOES THE COMPLAINT RELATE TO: DEVICE PLACEMENT/DEVICE REMOVAL/OBSERVATION PRIOR TO PATIENT CONTACT WHEN THE PHYSICIAN ATTEMPTED TO INSERT A WIRE GUIDE. 4 WHAT IS THE REORDER NUMBER, OUTER DIAMETER AND LENGTH OF THE WIRE GUIDE THAT WAS USED WITH THIS DEVICE IN THIS PROCEDURE? OLYMPUS / VISIGLIDE 0.025. 5 WAS THE WIRE GUIDE LUBRICATED PRIOR TO USE? YES. 6 WAS THE DEVICE AT THE CENTRE OF THE COMPLAINT INSPECTED FOR DAMAGE PRIOR TO USE? YES 7 WAS THE WIRE GUIDE INSPECTED FOR DAMAGE PRIOR TO USE? YES. 8 WERE PREVIOUS PROCEDURES I.E. SPHINCTEROTOMY ETC. CARRIED OUT PRIOR TO PLACING THE COMPLAINT DEVICE? YES. 9 IF YES PLEASE INDICATE THE PROCEDURE PERFORMED. 10 DID THE PATIENT INVOLVED EXHIBIT ALTERED ANATOMY OR TORTUOUS ANATOMY? NO. 11 IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED? ANOTHER DEVICE OF SAME RPN (LOT UNKNOWN) WAS USED. 12 DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? NO. 15 WERE ANY OTHER DEFECTS OBSERVED ON THE DEVICE PRIOR TO RETURN (OTHER THAN THE REPORTED COMPLAINT ISSUE)? NO. 16 WAS A STRAIGHTENER USED TO STRAIGHTEN THE STENT? YES. 17 (IF ANY DAMAGES WERE CONFIRMED PRIOR TO USE) WAS THE PACKAGE DAMAGED? NO. FOR COMPLAINTS OCCURRING DURING USE (ONCE IN CONTACT WITH ENDOSCOPE) ALSO ASK: 2 WHAT IS THE ENDOSCOPE MANUFACTURER, THE MODEL NUMBER AND WORKING CHANNEL SIZE THAT WAS USED FOR THE PROCEDURE? TJF-260V. 3 DOES YOUR MEDICAL FACILITY HAVE A SERVICE/MAINTENANCE SCHEDULE ASSOCIATED WITH ITS ENDOSCOPES? YES. 6 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE TO THE TARGET LOCATION? NO.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 21 MAY 2025.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 884601 | ZIMMON BILIARY STENT SET | FGE, STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | FGE | COOK MEDICAL IRELAND | G21393 | C2037540 | 10827002213934 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |