BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1812562 · Received August 16, 2010

    Report

    Report Number
    2953144-2010-01654
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 22, 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
    TN, 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: CLIP MISLOCATION, DETACHMENT-EXCHANGE SHEATH. TIME OF DEVICE ISSUE: DURING VESSEL CLOSURE. ADVERSE EVENT: FAILURE TO ACHIEVE HEMOSTASIS, PSEUDOANEURYSM. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, BLEEDING CONTINUED AND THE CLIP WAS NOTED TO BE DEPLOYED ON THE DISTAL END OF THE DEVICE. ADDITIONALLY, THE EXCHANGE SHEATH BECAME DISENGAGED FROM THE CLIP APPLIER DURING DEPLOYMENT OR WAS NEVER FULLY CONNECTED AT THE START OF THE PROCEDURE. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. A PSEUDOANEURYSM WAS IDENTIFIED THAT WAS TREATED WITH AN INJECTION OF THROMBIN. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION 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 77033-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention