BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROCOIL EMBOLIC SYSTEM (HES)

    MDR report key: 831294 · Received March 21, 2007

    Report

    Report Number
    2032493-2007-00001
    Event Type
    Injury
    Date Received
    March 21, 2007
    Date of Event
    March 1, 2007
    Report Date
    March 2, 2007
    Manufacturer
    MICROVENTION INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED. THERE WAS EVIDENCE THAT THE COIL HAD BROKEN FROM THE DELIVERY PUSHER. NO DEVICE DEFECTS WERE IDENTIFIED. IT WAS NOTED THAT AN EXCEL-14 MICRO-CATHETER WAS USED TO DEPLOY THE COIL. THE HES INSTRUCTIONS FOR USE SPECIFY THAT THIS MICRO-CATHETER SHOULD NOT BE USED WITH AN HES-14 COIL. SINCE THE COIL WAS AT THE 5 MINUTE LIMIT OF REPOSITION TIME, THE OUTER POLYMER LAYER OF THE COIL HAD EXPANDED. SINCE THE INNER LUMEN OF THE MICRO-CATHETER WAS NOT LARGE ENOUGH, THIS RESULTED IN RESISTANCE OF THE COIL AS IT WAS BEING RETRACTED. THIS IS THE MOST LIKELY CAUSE OF THE COIL BREAKING FROM THE DELIVERY PUSHER.

    Description of Event or Problem · 1

    PHYSICIAN USED A 3-MM X 7-CM HES COIL IN THE TREATMENT OF AN OPHTHALMIC ANEURYSM. DURING DEPLOYMENT, VISUALIZATION WAS LOST. THIS OCCURRED AS THE 5 MINUTE LIMIT OF THE COIL REPOSITIONING APPROACHED. THIS TIME LIMIT IS INDICATED IN THE INSTRUCTIONS FOR USE. THE PHYSICIAN WAS NOT ABLE TO DETERMINE WITH CERTAINTY THAT THE COIL WAS SEATED IN THE ANEURYSM. AS THE PHYSICIAN RETRACTED THE COIL, IT DETACHED. IT WAS NOTED THAT THE COIL WAS PARTIALLY IN THE ANEURYSM AND PARTIALLY IN THE PARENT ARTERY. THE PHYSICIAN USED A SNARE TO SUCCESSFULLY RETRIEVE THE COIL. NO CLINICALLY IDENTIFIABLE INJURY OCCURRED IMMEDIATELY FOLLOWING THE PROCEDURE. HOWEVER, THERE WAS SOME SLIGHT INTIMAL ABRASION IN THE CAROTID ARTERY, MOST LIKELY FROM THE ACTIVITY OF TRYING TO RECOVER THE COIL. THE PT EXPERIENCED A TIA DURING HER ICU STAY AND HAD NO FEELING ON THE LEFT SIDE OF HER BODY. HOWEVER, IN THE MORNING, THE PT HAD FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROCOIL EMBOLIC SYSTEM (HES) EMBOLIZATION COIL HCG MICROVENTION INC. 140307HES-V P0608313

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention