BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMON BILIARY STENT SET

    MDR report key: 8235944 · Received January 10, 2019

    Report

    Report Number
    3001845648-2019-00013
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Date of Event
    December 12, 2018
    Report Date
    January 10, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    00827002257948
    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 (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). 1 X ZEBD-7-10 OF LOT # C1550149 WAS EVALUATED ON (B)(6) 2018. THE DEFECTS OBSERVED IN THE LAB EVALUATION SLIGHT KINK AT THE 2ND PORTHOLE AT THE TAPERED END AND KINKS AT THE 5TH PORTHOLE ON THE TAPERED END AND THE NON-TAPERED END. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE OF LOT # C1526460 DID NOT REVEAL ANY DISCREPANCY RELATED TO THE COMPLAINT ISSUE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT # C1526460 UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT # C1526460. PRIOR TO DISTRIBUTION ALL ZIMMON BILARY STENT SET ZEBD-7-10 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.¿ ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED AS THE EXACT OPERATIONAL CONDITIONS OF USE COULD NOT BE REPLICATED IN THE LABORATORY SETTING. A POSSIBLE ROOT CAUSE FOR THIS COMPLAINT MAY BE DUE TO THE USE OF AN INAPPROPRIATE SIZE WIRE GUIDE. THE COMPLAINT INFORMATION INDICATED THAT A 0.025¿ WIRE GUIDE WAS USED FOR THE PROCEDURE. IT MAY BE NOTED THE DEVICE LABEL INDICATES THAT A 0.035¿ WIRE GUIDE IS REQUIRED FOR USE WITH THE OA DEVICE. AS THE SMALLER DIAMETER 0.025¿ WIRE GUIDE OCCUPIES LESS SPACE IN THE LUMEN OF THE PIGTAIL STENT IT IS LIKELY THAT THE EXTENT OF THE CURVATURE OF THE PIGTAIL WILL BE GREATER WHEN A 0.025. SUMMARY: 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

    FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT KINKED/BENT" AND "DIFFICULT ADVANCEMENT". THE DEVICE WAS TO BE USED FOR STENT PLACEMENT IN THE INTRAHEPATIC BILE DUCT. AFTER PLACING BOSTON'S WIRE GUIDE "PATHCOURSE 0.025INCH" IN THE B2 AREA, THE PHYSICIAN STRAIGHTENED THE STENT WITH THE STRAIGHTENER IN ORDER TO ADVANCE THE STENT OVER THE WIRE GUIDE. HOWEVER, BECAUSE THE WIRE GUIDE COULD NOT PASS THROUGH THE STENT DUE TO KINK, ANOTHER STENT WAS USED INSTEAD. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

    Description of Event or Problem · 0

    THE DEVICE WAS TO BE USED FOR STENT PLACEMENT IN THE INTRAHEPATIC BILE DUCT. AFTER PLACING BOSTON'S WIRE GUIDE "PATHCOURSE 0.025 INCH" IN THE B2 AREA, THE PHYSICIAN STRAIGHTENED THE STENT WITH THE STRAIGHTENER IN ORDER TO ADVANCE THE STENT OVER THE WIRE GUIDE. HOWEVER, BECAUSE THE WIRE GUIDE COULD NOT PASS THROUGH THE STENT DUE TO KINK, ANOTHER STENT WAS USED INSTEAD. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29494 ZIMMON BILIARY STENT SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD G25794 C1550149 00827002257948

    Patients

    Seq Age Sex Outcome Treatment
    1