BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1190424 · Received October 6, 2008

    Report

    Report Number
    2953144-2008-01628
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 18, 2008
    Manufacturer
    ABBOTT VASCULAR INREDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. THE LOT NUMBER WILL BE PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFORMATION.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: THUMB ADVANCER RESISTANCE. TIME OF DEVICE MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, DURING STEP 3 (SHEATH SPLITTING) THE OPERATOR FELT STRONG RESISTANCE WHILE ADVANCING THE THUMB ADVANCER. THE SAFETY RELEASE MECHANISM WAS ACTIVATED, RELEASING THE DEVICE FROM THE TISSUE TRACT. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED PATIENT ADVERSE EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention