BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1032117 · Received April 18, 2008

    Report

    Report Number
    2953144-2008-00748
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 27, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO RETURN FOR EVAL. IT HAS NOT YET BEEN RECEIVED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFO.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DIFFICULT TO REMOVE, PIECE DETACHMENT OF VESSEL LOCATOR WING. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: UNRETRIEVED PIECE OF VESSEL LOCATOR WING IN VESSEL. IT WAS REPORTED THAT A PHYSICIAN IN-TRAINING IN THE USE OF THE STARCLOSE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF A SCARRED COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, AFTER DEPLOYING THE CLIP, THE DEVICE WAS DIFFICULT TO REMOVE. THE SAFETY RELEASE BUTTON WAS ACTIVATED, BUT DID NOT RELEASE THE VESSEL LOCATOR WINGS. THE DEVICE WAS REMOVED WITH A FORCEFUL PULL. IT WAS NOTED THAT APPROX 1MM OF A VESSEL, LOCATOR WING WAS DETACHED AND REMAINED IN THE ARTERY, CONFIRMED WITH ANGIOGRAPHY. THE PHYSICIAN DECIDED TO LEAVE THE DETACHED PART IN THE VESSEL AND AGGRESSIVELY MONITOR THE PT. THE STARCLOSE CLIP ACHIEVED HEMOSTASIS BUT FIVE MINS OF MANUAL COMPRESSION WAS APPLIED PROPHYLACTICALLY. THOUGH REQUESTED, NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR-REDWOOD CITY NA 63007-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention