ZIMMON BILIARY STENT SET
Report
- Report Number
- 3001845648-2024-00448
- Event Type
- Malfunction
- Date Received
- August 9, 2024
- Date of Event
- July 11, 2024
- Report Date
- January 21, 2025
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- UDI-DI
- 10827002213965
- PMA / PMN Number
- K851962
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PMA/510(K) # K851962. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
DEVICE EVALUATION 1 UNIT OF LOT: C2115460 OF ZEBD-7-7 WAS RETURNED NOT IN ITS ORIGINAL PACKAGING. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON 08 AUGUST 2024. ON EVALUATION OF THE DEVICES THE FOLLOWING OBSERVATIONS WERE MADE: VISUAL INSPECTION: STENT RETURNED WITH PIGTAIL STRAIGHTENER IN CORRECT ORIENTATION. KINK OBSERVED ON THE 3RD PORTHOLE OF THE NON-TAPERED END OF PIGTAIL CURL. FUNCTIONAL INSPECTION: 0.035-INCH WIRE GUIDE DOES NOT PASS THE KINKS. VERNIER CALLIPERS USED: IPE0290 IT SHOULD BE NOTED THAT THIS FILE IS RELATED TO ANOTHER COMPLAINT FILE. FOR DETAILS OF THE OTHER INVESTIGATION PLEASE REFER TO (B)(4). MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION, ALL ZEBD-7-7 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ZEBD-7-7 OF LOT NUMBER: C2115460 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. REVIEW HISTORICAL DATA: THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED FOR THIS WORK ORDER. INSTRUCTIONS FOR USE AND/LABEL IT SHOULD BE NOTED THAT IN THE JAPANESE PACKAGING INSERT (C-ES0202M18) STATES: "REMOVE THIS PRODUCT FROM THE PACKAGE AND INSPECT WITH PARTICULAR ATTENTION TO BENDS, KINKS AND BREAKS". IT ALSO SAYS," CHOOSE A WIRE GUIDE WITH OUTER DIAMETER 0.035 INCH (0.89MM) FOR USE WITH THIS PRODUCT¿. THE JAPANESE PACKAGING INSERT (C-ES0202M18) SUPPLIED WITH THE DEVICE COMPLIES WITH MHLW LAW NO. 84 OF 2013 WHICH AVOIDS INCLUDING INFORMATION THAT IS NOT SPECIFIC TO THE MEDICAL DEVICE OR THAT WHICH IS BASIC KNOWLEDGE ALREADY UNDERSTOOD BY THE HEALTHCARE PROFESSIONAL, TO ENSURE TO ACCURATELY CONVEY ALL THE INFORMATION THAT IS IMPORTANT FOR THE USER. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0045-7 WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO; "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 (IFU0045-7). IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF USER ERROR WAS ESTABLISHED. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU AND/OR LABEL. FROM THE INFORMATION AVAILABLE, THE USER USED A 0.025-INCH WIRE GUIDE INSTEAD OF THE REQUIRED 0.035-INCH WIRE GUIDE. IT MAY BE NOTED THAT THE USE ERROR OF A 0.025" WIRE GUIDE LED TO THE KINKS ON THE NON-TAPERED END OF THE STENT. USE ERROR COMPLAINTS ARE CONSIDERED FORESEEN MISUSE. IT IS UNKNOWN HOW THE DEVICE WILL PERFORM OUTSIDE OF INSTRUCTIONS FOR USE AND/OR LABELLING REQUIREMENTS. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. 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: COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER AND/OR REP TESTIMONY. ACCORDING TO THE INITIAL REPORTER, NO HEALTH CONSEQUENCES OR IMPACTS WERE REPORTED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS. A DEFINITIVE ROOT CAUSE OF USER ERROR WAS DETERMINED. THE DEVICE WAS USED WITH 0.025-INCH WIRE GUIDE. IT MAY BE NOTED THAT THE USE ERROR OF A 0.025" WIRE GUIDE LED TO THE KINKS ON THE NON-TAPERED END OF THE STENT. CAPA 387756 HAS BEEN INITIATED FROM COMPLAINTS RELATED TO USE ERROR IN PRACTICE A 0.025¿ WIRE GUIDE IS BEING USED.
ZEBD-7-7 WAS TO BE PLACED IN COMMON BILE DUCT. GUIDE WIRE (OLYMPUS/VISIGLIDE 0.025 ANGLED) HAD ALREADY BEEN INSERTED IN BILE DUCT. THE PHYSICIAN EXTENDED THE PIGTAIL PART USING STRAIGHTENER AND ADVANCED IT ALONG THE GUIDE WIRE, BUT PROXIMAL PIGTAIL DIDN'T PASS THE GUIDE WIRE. HE FOUND THE KINK AND DISCONTINUED TO USE IT. HE COMPLETED THE PROCEDURE USING ANOTHER DEVICE OF SAME RPN (UNKNOWN LOT) WITHOUT ANY PROBLEMS. PATIENT OUTCOME: NO HEALTH HAZARD. PATIENT/EVENT INFO - NOTES: FOR ALL COMPLAINTS: 1 FOR ALL COMPLAINTS, ASK: DOES THE COMPLAINT RELATE TO:DEVICE PLACEMENT/DEVICE REMOVAL/OBSERVATION PRIOR TO PATIENT CONTACT PRIOR TO PATIENT CONTACT. 2 WHAT WAS THE TARGET LOCATION FOR THE STENT? COMMON BILE DUCT. 3 PLEASE DESCRIBE THE STORAGE CONDITIONS OF THE DEVICE PRIOR TO USE ESPECIALLY THOSE PERTAINING TO TEMPERATURE AND LIGHT EXPOSURE. IT WAS STORED VERTICALLY. 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 ANGLED. 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. EST. 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? REPLACE TO ANOTHER DEVICE OF SAME RPN. 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. 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? OLYMPUS JF-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. 9 HOW DID THE PHYSICIAN DETERMINE THE LENGTH OF THE STENT TO BE USED FOR THE PROCEDURE? FLUOROSCOPY. 10 WHERE WAS THE STRICTURE LOCATED IN THE DUCT? COMMON BILE DUCT. 11 WAS THE STRICTURE DILATED PRIOR TO PLACING THE DEVICE? NO. 16 DID ANY SECTION OF THE DEVICE DETACH INSIDE THE ENDOSCOPE OR PATIENT? NO. 24 PLEASE INDICATE ANY OTHER ENDOSCOPIC ACCESSORIES (IF ANY) THAT CAME INTO CONTACT WITH THE STENT OR INTRODUCTION SYSTEM DURING THE PROCEDURE. NO. 25 DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? NO. 28 WERE ANY OTHER DEFECTS OBSERVED ON THE DEVICE PRIOR TO RETURN (OTHER THAN THE REPORTED COMPLAINT ISSUE)? NO.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 21-JAN-2024.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1703012 | ZIMMON BILIARY STENT SET | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | G21396 | C2115460 | 10827002213965 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |