BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1705913 · Received May 28, 2010

    Report

    Report Number
    2953144-2010-00960
    Event Type
    Injury
    Date Received
    May 28, 2010
    Date of Event
    May 3, 2010
    Report Date
    May 3, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). PATIENT SELECTION. DEVICE #2: PART #14679-02, LOT #87006-6H IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    DEVICE ISSUE: RESISTANCE DURING THUMB ADVANCER STROKE AND CLIP FAILED TO DEPLOY. TIME OF DEVICE ISSUE: DURING VESSEL CLOSURE. ADVERSE EVENT: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A HEAVILY CALCIFIED FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, RESISTANCE WAS FELT DURING ADVANCEMENT OF THE THUMB ADVANCER, RESULTING IN THE CLIP NOT DEPLOYING. THE SAFETY RELEASE MECHANISM WAS USED TO REMOVE THE DEVICE. A SECOND STARCLOSE SE DEVICE WAS USED WITH THE SAME RESULTS. THE SAFETY RELEASE MECHANISM WAS USED TO REMOVE THE DEVICE AND HEMOSTASIS WAS ACHIEVED USING A THIRD STARCLOSE SE DEVICE. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 87006-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DEVICE #2: PART #14679-02, LOT #87006-6H