BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1022554 · Received March 31, 2008

    Report

    Report Number
    2953144-2008-00220
    Event Type
    Injury
    Date Received
    March 31, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 6, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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: NONE. SYMPTOMS/AE: THROMBOSIS. TIME OF SYMPTOMS/AE: DURING VESSEL CLOSURE. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF A STARCLOSE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE PHYSICIAN DEPLOYED THE CLIP INSIDE THE ARTERY CAUSING THE FEMORAL ARTERY TO THROMBUS. THE CLIP WAS REMOVED VIA SURGERY AND THE ARTERY WAS SUTURED. THERE WERE NO REPORTED ADVERSE PT SEQUELAE. 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 Required Intervention