BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FGE CATHETER, BILIARY, DIAGNOSTIC

    MDR report key: 8933814 · Received August 27, 2019

    Report

    Report Number
    3001845648-2019-00437
    Event Type
    Malfunction
    Date Received
    August 27, 2019
    Date of Event
    July 22, 2019
    Report Date
    August 26, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K851962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR RETURN THEREFORE A DOCUMENT BASED INVESTIGATION WILL BE COMPLETE. PRIOR TO DISTRIBUTION TTSO 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. A REVIEW OF THE MANUFACTURING RECORDS FOR THE TTSO DEVICE COULD NOT BE COMPLETE AS THE LOT NUMBER IS UNKNOWN. AS PER INSTRUCTIONS FOR USE, IFU0045-7, NOTES SECTION: ¿RETAIN THE POSITIONING SLEEVE (IF ANY): FOR USE WHEN INTRODUCING THE STENT FLAPS INTO THE ACCESSORY CHANNEL¿ INSTRUCTIONS FOR USE SECTION: ¿GENTLY ENSURE FULL EXTENSION OF ALL SIDE FLAPS*. LOAD POSITIONING SLEEVE ONTO DUODENAL FLAP END OF STENT.¿ ¿INTRODUCE STENT, TAPERED TIP FIRST, AND POSITIONING SLEEVE ONTO A PRE-POSITIONED WIRE GUIDE.¿ THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO USER TECHNIQUE. COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INFORMATION REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. AS PER INFORMATION PROVIDED BY REP: "THE CUSTOMER JUST WANTED TO LET ME KNOW ABOUT THE ISSUE, IN THE END THE STENT WAS PLACED AND THERE WAS NO NEED TO REPLACE IT IN THE MOMENT (THEY ONLY GOT AWARE THE FLAP TORE OFF WHEN CLEANING THE ENDOSCOPE)". COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT FRACTURE' AND 'DIFFICULT ADVANCEMENT'. WHEN PLACING THE STENT A FLAP OF THE STENT TORE OFF IN THE ENDOSCOPE AT THE 'ALBARAN' LEVER.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROGRESS, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    WHEN PLACING THE STENT A FLAP OF THE STENT TORE OFF IN THE ENDOSCOPE AT THE 'ALBARAN' LEVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728816 FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1