BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1440146 · Received August 13, 2009

    Report

    Report Number
    2953144-2009-01069
    Event Type
    Injury
    Date Received
    August 13, 2009
    Date of Event
    July 17, 2009
    Report Date
    July 27, 2009
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STARCLOSE INSTRUCTIONS FOR USE (IFU) INDICATIONS FOR USE STATES: "THE STARCLOSE VASCULAR CLOSURE SYSTEM IS INDICATED FOR THE PERCUTANEOUS CLOSURE OF COMMON FEMORAL ARTERY ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS, AMBULATION, AND DISCHARGEABILITY IN PTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR CATHETERIZATION PROCEDURES UTILIZING A 5F OR 6F PROCEDURAL SHEATH." THE SAFETY AND EFFECTIVENESS OF THE STARCLOSE SE VASCULAR CLOSURE SYSTEM HAVE NOT BEEN ESTABLISHED IN PTS IN "PTS WHO ARE MORBIDLY OBESE." THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DIFFICULT TO DEPLOY- THUMB ADVANCER, CLIP MISLOCATION. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE SUPERFICIAL FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, ALTHOUGH RESISTANCE WAS MET, THUMB ADVANCER DEPLOYMENT WAS COMPLETED. AFTER CLIP DEPLOYMENT, BLEEDING CONTINUED. WHEN THE DEVICE WAS REMOVED, IT WAS NOTICED THAT THE CLIP DEPLOYED IN THE DISTAL END OF THE EXCHANGE SHEATH. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL 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 71031-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention