BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMON BILIARY STENT SET

    MDR report key: 8073907 · Received November 15, 2018

    Report

    Report Number
    3001845648-2018-00530
    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
    00827002221222
    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 MFR SITE AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. (B)(4). 1 X ZEBD-5-10 OF LOT NUMBER: C1514678 WAS RETURNED TO CIRL FOR AN EVALUATION. 1 X ZEBD-5-10 OF LOT NUMBER: C1514678 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 PROXIMAL OF THE STENT. A 0.035 INCH WIRE GUIDE PASSED THROUGH WITH SLIGHT RESISTANCE. 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 # C1514678 DID NOT REVEAL ANY DISCREPANCY RELATED TO THE COMPLAINT ISSUE. PRIOR TO DISTRIBUTION ALL ZIMMON BILARY STENT SET ZEBD-5-10 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 FOR "STENT KINKED/ BENT". WHEN THE PHYSICIAN ADVANCED THE STENT OVER A WIRE GUIDE WHILE STRAIGHTENING THE STENT WITH A STRAIGHTENER, HE FELT RESISTANCE. THEN, HE CONFIRMED THAT THE STENT BECAME KINKED, SO ANOTHER ZEBD-5-10/C1478264 WAS USED INSTEAD TO FINISH THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

    Description of Event or Problem · 0

    WHEN THE PHYSICIAN ADVANCED THE STENT OVER A WIRE GUIDE WHILE STRAIGHTENING THE STENT WITH A STRAIGHTENER, HE FELT RESISTANCE. THEN, HE CONFIRMED THAT THE STENT BECAME KINKED, SO ANOTHER ZEBD-5-10/C1478264 WAS USED INSTEAD TO FINISH THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914103 ZIMMON BILIARY STENT SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD G22122 C1514678 00827002221222

    Patients

    Seq Age Sex Outcome Treatment
    1