BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM 3D DETACHABLE COIL

    MDR report key: 1021927 · Received March 28, 2008

    Report

    Report Number
    2029214-2008-00049
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 28, 2008
    Report Date
    February 28, 2008
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT HAS BEEN RETURNED AND IS BEING EVALUATED. A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETED.

    Description of Event or Problem · 1

    COILING TREATMENT OF A BASILAR TIP ANEURYSM. IT WAS REPORTED THE COIL WAS PARTIALLY PLACED AND REQUIRED MANIPULATION TO RE-POSITION A COIL LOOP INTO THE ANEURYSM. DURING THE RE-POSITIONING OF THE COIL, THE COIL DETACHED IN THE CATHETER. THE PHYSICIAN WAS ABLE TO PUSH THE REMAINDER OF THE COIL INTO THE ANEURYSM. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIUM 3D DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-3-6-3D 5087172

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK