BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1060670 · Received June 13, 2008

    Report

    Report Number
    2953144-2008-01050
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    July 6, 2006
    Report Date
    May 23, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    STUDY EVENT: 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: DEVICE DID NOT ADEQUATELY CAPTURE THE ARTERY. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. TIME OF AE: DURING THE VESSEL CLOSURE. IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING THE STARCLOSE DEVICE AFTER AN INTERVENTIONAL CAROTID ARTERY STENTING PROCEDURE. REPORTEDLY, THE STARCLOSE DEVICE DID NOT APPEAR TO ADEQUATELY CAPTURE THE ARTERY. PRESSURE WAS HELD WITH A SYVEK PATCH UNTIL HEMOSTASIS WAS ACHIEVED. THERE WERE NO ADVERSE PATIENT SEQUELAE REPORTED. ALTHOUGH REQUESTED, THERE IS NO ADDITIONAL INFORMATION 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 RX ACCULINK| HEPARIN| RX ACCUNET