BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROCOIL 14-SYSTEM COIL (HES)

    MDR report key: 1901401 · Received October 28, 2010

    Report

    Report Number
    2032493-2010-00030
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 27, 2010
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ANALYSIS: NO EVALUATION HAS BEEN PERFORMED ON THE COMPLAINT SAMPLE AS A PORTION REMAINS IN THE PATIENT AND THE DELIVERY PUSHER WAS DISCARDED BY THE USER. THE ROOT CAUSE CAN NOT BE DETERMINED AT THIS TIME. THE DEVICE HISTORY RECORD WAS REVIEWED. NO ABNORMAL DISCREPANCIES OR NON-CONFORMANCES WERE OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ADVANCEMENT OF AN EMBOLIZATION COIL THROUGH A MICROCATHETER INTO AN INTRACRANIAL ANEURYSM, THE COIL PREMATURELY DETACHED. AN UNSUCCESSFUL ATTEMPT WAS MADE TO RETRIEVE THE COIL USING AN INTRAVASCULAR SNARE. DURING THIS SNARE ATTEMPT, THE COIL WAS STRETCHED. AT THE END OF THE PROCEDURE, THE PLATINUM WIRE USED IN COIL CONSTRUCTION REMAINED IMPLANTED, ITS LENGTH EXTENDING FROM THE INTRACRANIAL VASCULATURE TO THE PERIPHERAL ARTERIAL ACCESS SITE. NO HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROCOIL 14-SYSTEM COIL (HES) EMBOLIZATION COIL HCG MICROVENTION, INC. 140515HES-V 10071317

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention