BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1772244 · Received July 22, 2010

    Report

    Report Number
    2953144-2010-01453
    Event Type
    Injury
    Date Received
    July 22, 2010
    Date of Event
    June 29, 2010
    Report Date
    June 30, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE DEVICE WAS REC'D. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    DEVICE ISSUE: DIFFICULT TO DEPLOY-THUMB ADVANCER, FAILURE TO DEPLOY - CLIP, DEVICE DID NOT OPERATE AS EXPECTED-EXCHANGE SHEATH SPLITTING. 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 FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, ALTHOUGH RESISTANCE WAS MET, THUMB ADVANCER DEPLOYMENT WAS COMPLETED. DURING CLIP DEPLOYMENT, IT COULD NOT BE DEPLOYED. WHEN THE DEVICE WAS REMOVED, IT WAS NOTICED THAT THE EXCHANGE SHEATH WAS NOT COMPLETELY SPLIT AND "PART OF PLASTIC WAS LYING IN THE AREA OF THE VESSEL LOCATOR WINGS." MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR - REDWOOD CITY NA 88040-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HEPARIN