BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1022104 · Received March 25, 2008

    Report

    Report Number
    2953144-2008-00202
    Event Type
    Malfunction
    Date Received
    March 25, 2008
    Report Date
    March 4, 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 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: CLIP MISLOCATION. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT DURING A PSEUDOANEURYSM REPAIR IN AN UNSPECIFIED VESSEL, THE PHYSICIAN FOUND A STARCLOSE DEVICE IMPLANTED IN AN UNSPECIFIED LOCATION FROM A PREVIOUS ARTERIOTOMY CLOSURE PROCEDURE. INFO RELATED TO THAT PROCEDURE IS UNKNOWN BY THE SITE REPORTER. ADDITIONALLY, NO ABBOTT DEVICES WERE USED FOR THIS PROCEDURE. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1