BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FGE CATHETER, BILIARY, DIAGNOSTIC

    MDR report key: 9888838 · Received March 27, 2020

    Report

    Report Number
    3001845648-2020-00170
    Event Type
    Malfunction
    Date Received
    March 27, 2020
    Report Date
    October 6, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K851962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE UNKNOWN ZSS DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT DEVICE WAS RETURNED FOR EVALUATION, WITH THE ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION: N/A. ADDITIONAL INFORMATION WAS REQUESTED, TO AID THIS INVESTIGATION AND TO FIND OUT WHAT HAPPENED TO THE DEVICE THAT CAUSED IT TO FAIL DEPLOYING. HOWEVER, DUE TO THE CURRENT CIRCUMSTANCES AND RESTRICTIONS REGARDING COVID-19, ONLY ONE ATTEMPT FOR ADDITIONAL INFORMATION HAS BEEN MADE. NO RESPONSE HAS BEEN RECEIVED TO DATE. THE INVESTIGATION WILL BE UPDATED IN THE FUTURE IF ANY ADDITIONAL INFORMATION IS RECEIVED. DOCUMENT REVIEW INCLUDING IFU REVIEW: AS THE RPN AND LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ZSS 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. AS PER INSTRUCTIONS FOR USE (IFU0100-1) ¿VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE.¿ THE USER IS ALSO INSTRUCTED AS FOLLOWS: ¿CARE MUST BE EXERCISED WHEN STRAIGHTENING PIGTAIL CURL IN ORDER TO AVOID KINKING OR BREAKING THE STENT.¿ THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE LIMITED AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE USER TECHNIQUE, IT MAY BE POSSIBLE THAT A LARGE AMOUNT OF FORCE WHILE TRYING TO ADVANCE IT THROUGH THE PATIENT¿S ANATOMY WHICH IN TURN CAUSED THE GUIDING CATHETERS TO RECEIVE DAMAGE/KINK THUS CAUSING THE ADVANCEMENT ISSUE. ADDITIONALLY IT MAY ALSO BE POSSIBLE THAT INSUFFICIENT LUBRICANT WAS USED. AS THE DEVICE WAS NOT RETURNED FOR EVALUATION THE CAUSE OF THIS COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT HARM IS UNKNOWN HOWEVER THEY DID CONCLUDE THAT NO ADDITIONAL PROCEDURES WERE REQUIRED AND NO PART REMAINED IN THE PATIENT THEREFORE IT CAN BE ASSUMED THAT THERE WERE NO HEALTH CONSEQUENCES. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR EMERGING TRENDS.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION. COMPLAINT CALLED IN BY DM ON (B)(6) 2020. AS REPORTED TO CUSTOMER RELATIONS: "OVER A 6-MONTH PERIOD, WITH AN UNKNOWN QUANTITY OF PRODUCTS, THE CUSTOMER HAS EXPERIENCED DIFFICULTY WITH ADVANCEMENT AND/OR DEPLOYMENT OF THE DEVICES OVER THEIR GUIDING CATHETERS. THE DM HAS NOT SEEN THIS ISSUE OCCUR IN PERSON, THE COMMENTS CAME FROM THE TECHS TO THE NURSES TO THEM. THE DEVICES ARE ALWAYS SOLUS STENTS. THIS WAS REPORTED TO [THE DM] ~3 WEEKS AGO WHEN THE DM WAS AT THE FACILITY. THE DM LEARNED THAT THE CUSTOMER WAS USING A MYLICON/WATER MIXTURE AS A LUBRICANT. THE DM TOLD THE CUSTOMER NOT TO USE THAT, BUT TO USE KY INSTEAD, MOVING FORWARD. ON (B)(6) 2020, THE CUSTOMER TOLD THE DM THEY WERE STILL HAVING THIS PROBLEM, EVEN WITH THE KY LUBRICANT. NOTHING REMAINING IN PATIENT, NO ADDITIONAL PROCEDURES REQUIRED, NOTHING BREAKING OFF, AND THE DOCTOR (AT LEAST IN SOME CASES) IS USING ANOTHER DEVICE AS A REPLACEMENT FOR THE ORIGINALLY INTENDED DEVICE." FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿DIFFICULT ADVANCEMENT."

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    COMPLAINT CALLED IN BY DM ON 10MAR2020--DID 10MAR2020. AS REPORTED TO CUSTOMER RELATIONS: "OVER A 6-MONTH PERIOD, WITH AN UNKNOWN QUANTITY OF PRODUCTS, THE CUSTOMER HAS EXPERIENCED DIFFICULTY WITH ADVANCEMENT AND/OR DEPLOYMENT OF THE DEVICES OVER THEIR GUIDING CATHETERS. THE DM HAS NOT SEEN THIS ISSUE OCCUR IN PERSON, THE COMMENTS CAME FROM THE TECHS TO THE NURSES TO THEM. THE DEVICES ARE ALWAYS SOLUS STENTS. THIS WAS REPORTED TO [THE DM] ~3 WEEKS AGO WHEN THE DM WAS AT THE FACILITY. THE DM LEARNED THAT THE CUSTOMER WAS USING A MYLICON/WATER MIXTURE AS A LUBRICANT. THE DM TOLD THE CUSTOMER NOT TO USE THAT, BUT TO USE KY INSTEAD, MOVING FORWARD. ON -09MAR2020, THE CUSTOMER TOLD THE DM THEY WERE STILL HAVING THIS PROBLEM, EVEN WITH THE KY LUBRICANT. NOTHING REMAINING IN PATIENT, NO ADDITIONAL PROCEDURES REQUIRED, NOTHING BREAKING OFF, AND THE DOCTOR (AT LEAST IN SOME CASES) IS USING ANOTHER DEVICE AS A REPLACEMENT FOR THE ORIGINALLY INTENDED DEVICE." FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿DIFFICULT ADVANCEMENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351048 FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1