BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPLEX 10-SYSTEM COIL

    MDR report key: 3694695 · Received December 17, 2013

    Report

    Report Number
    2032493-2013-00084
    Event Type
    Injury
    Date Received
    December 17, 2013
    Date of Event
    October 3, 2013
    Report Date
    December 10, 2013
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ANALYSIS: AN EVAL OF THE ACTUAL COMPLAINT SAMPLE COULD NOT BE PERFORMED AS THE DEVICE REMAINS WITHIN THE PT. THE DELIVERY PUSHER WAS REPORTED TO BE DISCARDED. THE DEVICE HISTORY RECORD WAS REVIEWED. NO ABNORMAL DISCREPANCIES OR NON-CONFORMANCES WERE OBSERVED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED TO MICROVENTION, INC THAT DURING THE TREATMENT OF AN ANEURYSM, THE THIRD COIL WAS PLACED. UPON ADVANCING THE FINAL 2 CM OF THE COIL, THE MICROCATHETER BACKED OUT OF THE ANEURYSM. UPON ADVANCING THE COIL AGAIN, THE COIL CAME OUT OF THE ANEURYSM AND STRETCHED. NO INCIDENT DETAIL WAS PROVIDED INDICATING COMPLICATION, HARM OR INTERVENTION DURING THE INITIAL REPORT. THE FOLLOWING INCIDENT INFO WAS REPORTED TO MVI, INC VIA MEDWATCH REPORT BY U.S. MAIL FROM THE FDA (B)(4). "THE IMPLANT COIL WOULD NOT DEPLOY AT THE INTRACRANIAL ANEURYSM AND THEREFORE STRETCHED, REACHING THE FEMORAL ARTERY. THE TRAPPED COIL WAS SUTURED IN PLACE." PT INFO - PT IDENTIFIER, AGE, SEX AND WEIGHT ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659403 MICROPLEX 10-SYSTEM COIL EMBOLIZATION COIL HCG MICROVENTION, INC. 100206HS-V 130313H8

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention