BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1772216 · Received July 22, 2010

    Report

    Report Number
    2953144-2010-01451
    Event Type
    Injury
    Date Received
    July 22, 2010
    Date of Event
    June 25, 2010
    Report Date
    June 30, 2010
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): THE DEVICE WAS RECEIVED. INIVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    DEVICE ISSUE: FAILURE TO DEPLOY - THUMB ADVANCER, BENT - DISTAL END. 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 SE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, DURING THUMB ADVANCER DEPLOYMENT, DIFFICULTY WAS ENCOUNTERED, THE DISTAL END OF THE CLIP DELIVERY TUBE-SET BENT, AND THE EXCHANGE SHEATH SPLITTING COULD NOT BE COMPLETED. THE SPLITTING OF THE EXCHANGE SHEATH WAS COMPLETED BY CUTTING THE UNSPLIT PORTION MANUALLY. ALTHOUGH THE CLIP DEPLOYED IN THE INTENDED LOCATION, MANUAL COMPRESSION WAS APPLIED FOR TEN MINUTES TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR - REDWOOD CITY NA 88042-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention