BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT VASCULAR INC. VASCULAR CLOSURE SYSTEM

    MDR report key: 6600832 · Received May 26, 2017

    Report

    Report Number
    MW5070079
    Event Type
    Injury
    Date Received
    May 26, 2017
    Date of Event
    May 10, 2017
    Report Date
    May 26, 2017
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AT THE COMPLETION OF A PROCEDURE IN THE CARDIAC CATH LAB, THE PHYSICIAN INSERTED A STARCLOSE VASCULAR CLOSURE DEVICE, AND STEPS 1 THRU 3 WERE PERFORMED NORMALLY. DURING STEP 4 (TO RELEASE OR DEPLOY THE DEVICE), THE DEVICE FELT STUCK. UPON REMOVAL OF THE DEVICE, THE STARCLOSE CLOSURE DEVICE REMAINED WITHIN THE DEPLOYMENT DEVICE. THE PHYSICIAN APPLIED MANUAL PRESSURE TO THE ARTERIOTOMY SITE, AND HEMOSTASIS WAS ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377192 ABBOTT VASCULAR INC. VASCULAR CLOSURE SYSTEM VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR INC. STARCLOSE SE 7020941

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention