BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1800544 · Received August 12, 2010

    Report

    Report Number
    2953144-2010-01590
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 19, 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
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DEVICE ISSUE: DIFFICULT TO DEPLOY-THUMB ADVANCER, DIFFICULT TO REMOVE, CLIP MISLOCATION. 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 RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, ALTHOUGH DIFFICULTY WAS ENCOUNTERED DURING THUMB ADVANCER DEPLOYMENT, EXCHANGE SHEATH SPLITTING WAS COMPLETED. AFTER CLIP DEPLOYMENT, THE DEVICE WAS DIFFICULT TO REMOVE. A DILATOR WAS INSERTED INTO THE ACCESS PORTS AND THE SAFETY RELEASE WAS PUSHED, WHICH ALLOWED THE DEVICE TO BE REMOVED. AFTER THE DEVICE WAS REMOVED, THE CLIP WAS OBSERVED TO BE DEPLOYED ON THE DISTAL END OF THE CLIP DELIVERY TUBESET. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. 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 89005-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention GUIDE WIRE: IRON MAN| GUIDE CATH: LIMA| STENT: HERCULINK ELITE