BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET

    MDR report key: 7658503 · Received July 3, 2018

    Report

    Report Number
    7658503
    Event Type
    Malfunction
    Date Received
    July 3, 2018
    Date of Event
    June 16, 2018
    Report Date
    June 22, 2018
    Manufacturer
    STRYKER NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE TREATMENT OF A SUBARACHNOID HEMORRHAGE (SAH) BY THE DOCTOR, THE FIRST DETACHABLE FRAMING COIL WAS PLACED IN THE RUPTURED ANEURYSM (REF# 547730, LOT # 20413926, LAWSON NUMBER (B)(4)) BUT THE COIL DID NOT DETACH. A SECOND DETACHMENT DEVICE WAS USED AND THE DEVICE STILL DID NOT DETACH. EVENTUALLY A IZDS CONNECTING CABLE (REF# 451102-5, LAWSON # (B)(4)) WAS USED- THE LIGHT FOR ACKNOWLEDGMENT ON THE DETACHER DEVICE DID NOT LIGHT UP AND STILL NO DETACHMENT WAS POSSIBLE. THE COIL WAS REMOVED AND A NEW DEVICE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501462 TARGET DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR 20413926

    Patients

    Seq Age Sex Outcome Treatment
    1 14965 DA