BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1133151 · Received August 22, 2008

    Report

    Report Number
    2953144-2008-01380
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 28, 2008
    Report Date
    July 28, 2008
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DIFFICULT TO DEPLOY/MISLOCATION/DIFFICULT TO REMOVE. 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 RIGHT FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE PHYSICIAN PRESSED THE BUTTON TO DEPLOY THE CLIP, BUT THE CLIP WOULD NOT RELEASE. THE BUTTON WAS PRESSED A SECOND TIME IN WHICH THE CLIP DEPLOYED IN THE SUB-SKIN TISSUE AND REMAINED IN THE PATIENT. THE DEVICE COULD NOT BE REMOVED FROM THE PATIENT. THE PHYSICIAN FOLLOWED THE PROPER STEPS AND WAS ABLE TO REMOVE THE DEVICE. HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. 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 NA 65131-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention