BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1790770 · Received August 4, 2010

    Report

    Report Number
    2953144-2010-01542
    Event Type
    Injury
    Date Received
    August 4, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 13, 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
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - PATIENT SELECTION, AGAISNT RESISTANCE. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    DEVICE ISSUE: DIFFICULT TO REMOVE, BENT EXCHANGE SHEATH, CLIP ON DISTAL END. TIME OF DEVICE ISSUE: DURING VESSEL CLOSURE. SYMPTOM/AE: 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 AN INTERVENTIONAL PROCEDURE. REPORTEDLY, ALTHOUGH RESISTANCE WAS MET, THUMB ADVANCER DEPLOYMENT WAS COMPLETED. DURING CLIP DEPLOYMENT, THE EXCHANGE SHEATH BENT. WHEN THE DEVICE WAS REMOVED, IT WAS NOTICED THAT THE CLIP DEPLOYED ON THE DISTAL END OF THE DEVICE. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO ADD'L INFO 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 89006-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention