BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPLEX (MCS) 10-SYSTEM COIL

    MDR report key: 2823813 · Received October 29, 2012

    Report

    Report Number
    2032493-2012-00049
    Event Type
    Injury
    Date Received
    October 29, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ANALYSIS: A VISUAL ANALYSIS REVEALED THE DEVICE IMPLANT COIL RETURNED KNOTTED IN A MASS CONTAINED IN A 20ML SYRINGE WITH SALINE/BLOOD. THE COIL IS COMPLETELY STRETCHED INTO WIRE. THE DELIVERY PUSHER WAS RETURNED WITH IMPLANT COIL DETACHED FROM THE ATTACHMENT ZONE. THE ATTACHMENT TETHER THAT HOLDS THE IMPLANT INTACT WITH THE DELIVERY PUSHER HAS CHARACTERISTICS AND EVIDENCE OF BEING STRETCHED. THE ROOT CAUSE OF THIS COMPLAINT APPEARS TO BE DUE TO THE DEVICE BEING EXPOSED TO A FORCE THAT EXCEEDED THE MAXIMUM TENSILE SPECIFICATION OF THE ATTACHMENT MONOFILAMENT. THE MICROCATHETER USED WITH THIS DEVICE WAS NOT RETURNED FOR EVALUATION. WE CANNOT DETERMINE IF THIS WAS AN ATTRIBUTING FACTOR. 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 THE TREATMENT OF A LARGE ANEURYSM, THE EMBOLIZATION COIL PREMATURELY DETACHED PARTIALLY WITHIN THE ANEURYSM AND THE MICROCATHETER. A PORTION OF THE COIL EXTENDED INTO THE PARENT ARTERY. AN ATTEMPT WAS MADE TO RETRIEVE THE COIL USING A SNARE. A PORTION OF THE COIL WAS RETRIEVED. ON (B)(6) 2012, THE PATIENT WAS STILL VENTILATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROPLEX (MCS) 10-SYSTEM COIL EMBOLIZATION COIL HCG MICROVENTION, INC. VFC061030-V 12071920

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention