BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDUSA MULTI-COIL

    MDR report key: 6440218 · Received March 28, 2017

    Report

    Report Number
    3009688825-2017-00001
    Event Type
    Malfunction
    Date Received
    March 28, 2017
    Date of Event
    March 2, 2017
    Report Date
    April 19, 2017
    Manufacturer
    ENDOSHAPE, INC.
    Product Code
    KRD
    UDI-DI
    10857798005017
    PMA / PMN Number
    K140796
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EMBOLIZATION DEVICES FROM SAME LOT EVALUATED. NO DEFECT FOUND IN EVALUATED DEVICES.

    Additional Manufacturer Narrative · 1

    EMBOLIZATION DEVICE WAS NOT EXPLANTED. DELIVERY SYSTEM WAS RETURNED FOR EVALUATION. NO DEVICE DEFECT FOUND IN RETURNED DELIVERY SYSTEM. DETACH SLIDE FOUND IN POSITION PARTWAY THROUGH DETACH TRAVEL. USER REPORTED INITIAL PARTIAL DEPLOYMENT BEYOND THE MAXIMUM DISTANCE BEFORE RETRACTION RECOMMENDED IN THE IFU.

    Description of Event or Problem · 1

    THE DEVICE DID NOT FORM THE EXPECTED COIL PACK WHEN FIRST PARTIALLY DEPLOYED IN AN ESTIMATED 15.8 MM VENOUS ANEURYSM. THE DEVICE WAS PARTIALLY DEPLOYED FARTHER THAN IS RECOMMENDED BEFORE RETRACTION. THE PHYSICIAN RETRACTED THE DEVICE, REPOSITIONED, AND DEPLOYED AGAIN. DURING THIS SECOND ATTEMPT, THE DEVICE BECAME COMPLETELY DETACHED, PRESENTING AN EMBOLISM RISK. THE PHYSICIAN HELD THE DEVICE IN PLACE AND PLACED THREE SUTURES TO IMMOBILIZE THE DEVICE. THE PATIENT DID NOT SUFFER ANY ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220965 MEDUSA MULTI-COIL VASCULAR EMBOLIZATION DEVICE KRD ENDOSHAPE, INC. MMC-122 1004356 10857798005017

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention