BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1181706 · Received September 30, 2008

    Report

    Report Number
    2953144-2008-01583
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 9, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DIFFICULT TO REMOVE. TIME OF DEVICE MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT THE DEVICE WAS DIFFICULT TO REMOVE FROM THE PT'S ARTERY. THE DEVICE WAS REMOVED USING COUNTER-TENSION AND AN ASSERTIVE PULL PER THE INSTRUCTIONS FOR USE (IFU). HEMOSTASIS WAS ACHIEVED WITH THE CLIP; HOWEVER, MANUAL COMPRESSION WAS USED FOR APPROXIMATELY ONE TO TWO MINUTES BECAUSE OF OOZING FROM THE TISSUE TRACK. THE TARGET SITE WAS HEAVILY SCARRED. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR REDWOOD CITY NA 67087-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR