BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1012474 · Received March 12, 2008

    Report

    Report Number
    2953144-2008-00130
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    January 31, 2008
    Report Date
    February 20, 2008
    Manufacturer
    ABBOTT VASCULAR - REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE WAS RETURNED FULLY CLIP DEPLOYED. THE EXTERNAL AND INTERNAL COMPONENTS WERE IN THE CORRECT POST DEPLOYED POSITION. NO STRIKE MARKS WERE FOUND ON THE GARAGE AND PUSHER BLOCKS TO INDICATE INTERFERENCE OF THE SAFETY RELEASE ROD DISTAL END. THE VESSEL BUTTON ENGAGED WITH THE SAFETY RELEASE NUT 10 OF 10 ATTEMPTS. NO DAMAGE, ABNORMALLY OR MFG ISSUE WAS DETECTED. THE DEVICE CONFORMED TO SPECIFICATION. THE ROOT CAUSE FOR THE REPORTED EXPERIENCE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCT ANY FINDINGS RELEVANT TO THIS INVESTIGATION. ADDITIONALLY, THE 690 UNUSED, STERILE DEVICES OF THE SAME LOT WERE RETURNED. EVALUATION OF REPRESENTATIVE SAMPLES FOUND NO MALFUNCTION. ALL DEVICES CONFORMED TO SPECIFICATION AND PASSED FUNCTIONAL TESTING WITH ACCEPTABLE RESULTS.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: PREMATURE COLLAPSE OF VESSEL LOCATOR WINGS. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT A PHYSICIAN, TRAINED IN THE USE OF THE STARCLOSE DEVICE, ATTEMPTED COMMON FEMORAL ARTERIOTOMY CLOSURE AFTER AN UNSPECIFIED PROCEDURE. DURING THUMB ADVANCEMENT, THE VESSEL LOCATOR BUTTON RELEASED RESULTING IN THE VESSEL LOCATOR WINGS PREMATURELY COLLAPSING AND VESSEL ACCESS LOSS. HEMOSTASIS WAS ACHIEVED WITH MANUAL COMPRESSION. THERE WAS NO ADVERSE PT EFFECT. THOUGH REQUESTED, NO ADDITIONAL 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 52095-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK