BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMON BILIARY STENT SET

    MDR report key: 8073468 · Received November 15, 2018

    Report

    Report Number
    3001845648-2018-00531
    Event Type
    Malfunction
    Date Received
    November 15, 2018
    Date of Event
    October 18, 2018
    Report Date
    November 15, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    00827002213968
    PMA / PMN Number
    K851962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    510 (K) NUMBER: K851962. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(6). COOK MEDICAL INCORPORATED (CMI), 1025 ACUFF ROAD, P.O BOX 4195, BLOOMINGTON, INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). 1 X ZEBD-7-7 OF LOT NUMBER C1512679 WAS RETURNED TO CIRL FOR AN EVALUATION ON 8TH OF NOVEMBER 2018. IN SUMMARY THE FOLLOWING RESULTS WERE OBSERVED IN THE LAB EVALUATION. A KINK WAS OBSERVED AT THE TAPER END OF STENT ON SECOND AND FIFTH PORT HOLES OF THE STENT. A 0.035 INCH WIRE GUIDE DID NOT PASS THE STENT. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. A DEFINITE ROOT CAUSE CANNOT BE DETERMINED, AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE CAUSE OF THIS COMPLAINT IS THAT THE KINK OCCURRED WHILE BEING STRAIGHTENED WHILE BEING PASSED OVER WIRE GUIDE. A PRECAUTION INCLUDED IN INSTRUCTIONS FOR USE, IFU0045-6 STATES "CARE MUST BE EXERCISED WHEN STRAIGHTENING THE PIGTAIL CURLS* IN ORDER TO AVOID KINKING OR BREAKING THE STENT." A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE OF LOT # C1512679 DID NOT REVEAL ANY DISCREPANCY RELATED TO THE COMPLAINT ISSUE. PRIOR TO DISTRIBUTION ALL ZIMMON BILARY STENT SET ZEBD-7-7 ARE SUBJECTED TO VISUAL AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE IN CIRL. THE INSTRUCTIONS FOR USE, IFU0045-6 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.¿ ALSO THE USER IS INSTRUCTED BY THE INSTRUCTIONS FOR USE, IFU0045-6 ¿CARE MUST BE EXERCISED WHEN STRAIGHTENING THE PIGTAIL CURLS IN ORDER TO AVOID KINKING OR BREAKING THE STENT.¿ THE REVIEW OF RELEVANT INFORMATION PROVIDED, THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. THE PATIENT DIDN¿T EXPERIENCE ANY ADVERSE AS RESULT OF THE DEVICE FAILURE AND BASED ON THE INFORMATION PROVIDED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    510 (K) NUMBER: K851962. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    THIS FILE IS BEING REPORTED BASED ON THE FDA MDR MALFUNCTION PRECEDENCE "STENT KINKED/ BENT." THE PHYSICIAN CAREFULLY STRAIGHTENED THE PIGTAIL USING THE STRAIGHTENER AND ADVANCED IT OVER A WIRE GUIDE (OLYMPUS' VISIGLIDE / SIZE UNKNOWN) BUT THE WIRE GUIDE WOULD NOT PASS THROUGH THE STENT LUMEN DUE TO KINK IN PIGTAIL. ANOTHER ZEBD-7-7 WAS USED INSTEAD TO FINISH THE PROCEDURE.

    Description of Event or Problem · 0

    THE PHYSICIAN CAREFULLY STRAIGHTENED THE PIGTAIL USING THE STRAIGHTENER AND ADVANCED IT OVER A WIRE GUIDE (OLYMPUS' VISIGLIDE / SIZE UNKNOWN) BUT THE WIRE GUIDE WOULD NOT PASS THROUGH THE STENT LUMEN DUE TO KINK IN PIGTAIL. ANOTHER ZEBD-7-7 WAS USED INSTEAD TO FINISH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913084 ZIMMON BILIARY STENT SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD G21396 C1512679 00827002213968

    Patients

    Seq Age Sex Outcome Treatment
    1