BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1210723 · Received October 23, 2008

    Report

    Report Number
    2953144-2008-01719
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    September 30, 2008
    Report Date
    October 1, 2008
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVAL. IT HAS NOT BEEN REC'D.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DIFFICULT TO DEPLOY/CARVING/DIFFICULT TO REMOVE. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS/SURGERY TO REMOVE. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, DURING ADVANCEMENT OF THE THUMB ADVANCER, RESISTANCE WAS FELT. ADD'L PRESSURE WAS APPLIED AND THE CLIP WAS DELIVERED. THE DEVICE COULD NOT BE REMOVED. THE ARTERY WAS COMPRESSED AND FORCE WAS USED TO REMOVE THE DEVICE. UPON DEVICE REMOVAL, THE VESSEL LOCATOR REMAINED INSIDE THE ARTERY AND A "METALIC THREAD" WAS REMOVED. AN ECHO-DOPPLER WAS PERFORMED AND THE ARTERY WAS "ALL RIGHT". HEMOSTASIS WAS ACHIEVED USING COMPRESSION MASSAGE. THERE WERE NO REPORTED ADVERSE PT EFFECTS. CLARIFICATION REQUESTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention