BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1833180 · Received September 9, 2010

    Report

    Report Number
    2953144-2010-01898
    Event Type
    Injury
    Date Received
    September 9, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 16, 2010
    Manufacturer
    ABBOTT VASCULAR - VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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

    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, WHEN THE PLUNGER WAS DEPRESSED, THE THUMB ADVANCER AND CLIP DELIVERY TUBE ADVANCED AND EXCHANGE SHEATH SPLITTING OCCURRED, HOWEVER, THE PLUNGER WOULD NOT REMAIN DEPRESSED IN THE LOCKED POSITION. THE OPERATOR DECIDED TO CONTINUE WITH DEVICE DEPLOYMENT AND HAD A SECOND PERSON HOLD THE PLUNGER DOWN WHILE DEVICE DEPLOYMENT WAS COMPLETED. WHEN THE DEVICE WAS REMOVED, THE CLIP WAS NOTED DEPLOYED IN THE INTENDED LOCATION WITH HEMOSTASIS BEING ACHIEVED. A LONG STRINGY SILVER OF EXCHANGE SHEATH MATERIAL WAS NOTED PROTRUDING OUT FROM THE TISSUE TRACT, WHICH WAS COMPLETELY REMOVED WITH FORCEPS. 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 - VASCULAR SOLUTIONS NA 80028-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention