BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASUCULAR CLOSURE SYSTEM

    MDR report key: 1790769 · Received August 4, 2010

    Report

    Report Number
    2953144-2010-01543
    Event Type
    Injury
    Date Received
    August 4, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 13, 2010
    Manufacturer
    ABBOTT VASCULAR - REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    DEVICE ISSUE: FAILURE TO DEPLOY - CLIP. TIME OF DEVICE ISSUE: DURING VESSEL CLOSURE. ADVERSE EVENT: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, DURING CLIP DEPLOYMENT, THE CLIP DID NOT DEPLOY, BUT STAYED IN THE DEVICE. MANUAL COMPRESSION AND A FEMOSTOP WERE USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASUCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR - REDWOOD CITY NA 89018-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention