BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FGE CATHETER, BILIARY, DIAGNOSTIC

    MDR report key: 12202401 · Received July 21, 2021

    Report

    Report Number
    3001845648-2021-00565
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Date of Event
    June 21, 2021
    Report Date
    June 14, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K851962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE INVOLVED IN THIS COMPLAINT WAS RETURNED TO CIRL WITHOUT ITS ORIGINAL PACKAGING FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WILL BE COMPLETE. LAB EVALUATION: LAB EVALUATION DATE: 13 JAN 2022. VISUAL INSPECTION: DAMAGE NOTED NEAR FLAP ON THE TAPERED END. FUNCTIONAL INSPECTION: N/A - RPN UNKNOWN. DOCUMENT REVIEW INCLUDING IFU REVIEW: AS THE RPN AND LOT NUMBER OF THE DEVICE ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL COTTON LEUNG DEVICES 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 OF WHICH ACCOMPANIES THIS DEVICE STATES THE FOLLOWING: THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED HIGH FORCE BEING APPLIED TO THE STENT AS IT WAS INSERTED INTO THE LOCKING DEVICE, LIKELY CAUSING ISSUE REPORTED AND OBSERVED DURING THE LAB EVALUATION. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    SUPPLEMENTAL FOLLOW UP REPORT IS BEING SUBMITTED DUE TO LAB EVALUATION COMPLETED ON 13 JAN 2022: ¿DAMAGE NOTED NEAR FLAP ON THE TAPERED END¿.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

    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 RECEIVED FROM DM (WITH INSUFFICIENT INFORMATION) VIA E-MAIL ON (B)(6) 2021--DID (B)(6) 2021. AS REPORTED TO CUSTOMER RELATIONS: "I MEANT TO SHARE THIS WITH YOU THIS MORNING. WE HAD A LOCKING DEVICE ((B)(4)) ON MONDAY THAT WE COULD NOT GET THE BILIARY STENT (PR335993) THOUGH AND ACTUALLY "MAULED" THE STENT. I SAVED BOTH OF THESE AND THE STENT PACKAGE FOR YOU. NO ADVERSE EFFECTS CURRENTLY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103814 FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown