BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1032162 · Received April 18, 2008

    Report

    Report Number
    2953144-2008-00758
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 1, 2008
    Report Date
    March 25, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: VESSEL LOCATOR WINGS COLLAPSED PREMATURELY. TIME OF 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 COMMON FEMORAL ARTERY, AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE VESSEL LOCATOR BUTTON RELEASED PREMATURELY COLLAPSING THE VESSEL LOCATOR WINGS WHILE PERFORMING THE DEPLOYMENT STEPS. THE VESSEL LOCATOR BUTTON WAS DEPRESSED A SECOND TIME AND REMAINED DEPRESSED. THE CLIP DEPLOYED SUCCESSFULLY AND ACHIEVED HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADD'L 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1