BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROSOFT ADVANCED

    MDR report key: 12744736 · Received November 3, 2021

    Report

    Report Number
    12744736
    Event Type
    Malfunction
    Date Received
    November 3, 2021
    Date of Event
    October 24, 2021
    Report Date
    October 27, 2021
    Manufacturer
    MICROVENTION INC.
    Product Code
    KRD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IR (INTERVENTIONAL RADIOLOGY) CEREBRAL ANGIOGRAM FOR SAH (SUBARACHNOID HEMORRHAGE) PERFORMED. INTERVENTION WITH COILING FOR BASILAR ARTERY ANEURYSM. INSPECTION OF DEVICE FOLLOWING DEPLOYMENT OF COIL INDICATED IT HAD ELONGATED BUT REMAINED INTACT. DEVICE PROVIDED TO MANUFACTURER FOR EXAMINATION. MANUFACTURER RESPONSE FOR HYDROCOIL 10, HYDROCOIL 10 (PER SITE REPORTER). DEVICE PROVIDED TO REPRESENTATIVE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1643907 HYDROSOFT ADVANCED DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICROVENTION INC. 7210-0254 2009151WR

    Patients

    Seq Age Sex Outcome Treatment
    1 21900 DA