BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2972502 · Received February 21, 2013

    Report

    Report Number
    2024168-2013-01015
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER SUCCESSFUL DEPLOYMENT OF THE STARCLOSE SE CLIP IN THE LEFT COMMON FEMORAL ARTERY, NO PULSE WAS DETECTABLE IN THE LEFT FOOT AFTER AN INTERVENTIONAL PROCEDURE. AN ULTRASOUND OF THE LEFT FEMORAL ARTERY WAS PERFORMED AND AN OCCLUSION WAS FOUND. THE CLIP WAS VISIBLE AT THE OCCLUSION. USING AN ACCESS FROM THE RIGHT COMMON FEMORAL ARTERY THE OCCLUSION WAS TREATED WITH BALLOON DILATATION. THE MEDICAL INTERVENTION WAS SUCCESSFUL AND THE PULSE IN THE LEFT FOOT WAS RESTORED. THE PROCEDURE WAS PROLONGED DUE TO THE BALLOON DILATATION TREATING THE OCCLUSION. THE PHYSICIAN IS REPORTEDLY TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76809 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 20808K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 8FHEPARIN