BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GWJ-32-200 GUIDEWIRE

    MDR report key: 12746248 · Received November 3, 2021

    Report

    Report Number
    9681477-2021-00019
    Event Type
    Malfunction
    Date Received
    November 3, 2021
    Date of Event
    October 8, 2021
    Report Date
    November 3, 2021
    Product Code
    DQX
    PMA / PMN Number
    K935170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE SPECIMEN DEVICE DOES NOT PRESENT ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD HAVE IMPACTED ON THE EVENT AS REPORTED. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. BASED ON THE INFORMATION PROVIDED BY THE SUPPORTING DOCUMENTATION, "PHYSICIAN PREFERENCE" AND/OR "UNKNOWN/UNCLEAR DUE TO INSUFFICIENT INFORMATION" MAY HAVE IMPACTED ON THE EVENT AS REPORTED.

    Description of Event or Problem · 1

    WHEN OPENED, THE TIP OF THE GUIDE WIRE CAME OUT OF THE HOOP. THE SPECIMEN WAS DISCARDED AT THE HOSPITAL AND WILL NOT BE RETURNED. (B)(6) 2021: ADDITIONAL INFORMATION: THE GUIDE WIRE SHOULD HAVE BEEN STORED IN THE HOOP, BUT IT WAS STICKING OUT OF THE HOOP LONGER THAN USUAL. (B)(6) 2021: ADDITIONAL INFORMATION: REGARDING (B)(4), WE INFORMED TOTALLY INCORRECT INFORMATION. MY SINCEREST APOLOGIES FOR MISLEADING YOU. THIS WAS A COMPLAINT ABOUT "CORE WIRE PENETRATION BETWEEN COIL WRAPS BEFORE OPENING THE POUCH". THIS MIGHT BE CAUSE BECAUSE THE GUIDEWIRE SLIPPED OUT FROM THE HOOP DISPENSER DURING TRANSPORTATION AND GUIDEWIRE GOT KINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1645311 GWJ-32-200 GUIDEWIRE GUIDEWIRE DQX GWJ-32-200 5816155

    Patients

    Seq Age Sex Outcome Treatment
    1