BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXT DETACHABLE COIL, HELIX SOFT

    MDR report key: 1200049 · Received October 15, 2008

    Report

    Report Number
    2029214-2008-00184
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 22, 2008
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE HAS BEEN EVALUATED AND CONFIRMED THE IMPLANT COIL HAD BROKEN FROM THE DELIVERY SYSTEM. BASED ON THE REPORTED DETAILS AND THE FINDINGS, THE COIL WAS LIKELY BROKEN DURING MANIPULATION OF THE DEVICE.

    Description of Event or Problem · 1

    DURING AN ANEURYSM COILING PROCEDURE, IT WAS REPORTED THAT DURING COIL DELIVERY, RESISTANCE ENCOUNTERED WHEN MOST PART OF THE COIL WERE INSIDE THE ANEURYSM. PHYSICIAN SUSPECTED THE COIL WAS STRETCHED AND DECIDED TO RETRIEVE THE COIL. AFTER THE COIL WAS OUT, THE COIL DETACHED AT THE DETACHMENT ZONE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXT DETACHABLE COIL, HELIX SOFT ELECTROLYTICALLY DETACHABLE COIL HCG EV3 NEUROVASCULAR N-2-1-T10-SO 5346745

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK