BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1071330 · Received July 8, 2008

    Report

    Report Number
    2953144-2008-01137
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 16, 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
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A F/U WILL BE SUBMITTED WITH ANY RELEVANT INFO.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: UNK. TIME OF SYMPTOMS/AE: DURING VESSEL CLOSURE. SYMPTOMS/AE; FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN IN-TRAINING IN THE USE OF THE STARCLOSE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A HEAVILY CALCIFIED RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, ALL DEPLOYMENT STEPS WERE COMPLETED; HOWEVER, HEMOSTASIS WAS NOT ACHIEVED AFTER CLIP DEPLOYMENT. HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THE PHYSICIAN COMMENTED THAT THE PT WAS EXTREMELY THIN AND IT COULD HAVE CONTRIBUTED TO THE DEVICE FAILURE. THERE WERE NO REPORTED ADVERSE PT EFFECT. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR REDWOOD CITY NA 64092-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention HEPARIN| SHEATH: 6FR