BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1011321 · Received March 11, 2008

    Report

    Report Number
    2953144-2008-00125
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 15, 2008
    Report Date
    February 15, 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
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: CLIP MISLOCATION. TIME OF DEVICE MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE STARCLOSE WAS DEPLOYED BUT FAILED TO ACHIEVE HEMOSTASIS. THE CLIP WAS NOTED TO HAVE DELIVERED ON THE SKIN. THE PHYSICIAN REMOVED THE CLIP BY AN UNKNOWN METHOD. HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR REDWOOD CITY NA 53137-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK