BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 3082847 · Received April 29, 2013

    Report

    Report Number
    2024168-2013-02651
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STARCLOSE SE DEVICE CLIP, WHICH IS MADE OF NICKEL-TITANIUM, WAS DEPLOYED IN A PATIENT WITH A HYPERSENSITIVITY TO NICKEL. THE INSTRUCTIONS FOR USE STATES UNDER CONTRAINDICATIONS THAT THE STARCLOSE SE VASCULAR CLOSURE SYSTEM IS CONTRAINDICATED FOR USE IN PATIENTS WITH KNOWN HYPERSENSITIVITY TO NICKEL-TITANIUM. IT IS INDICATED THAT THE DEVICE WAS DISCARDED AND IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN INTERVENTIONAL NEUROLOGICAL COILING PROCEDURE, ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ACHIEVED USING A STARCLOSE SE DEVICE. REPORTEDLY, ALTHOUGH THE PATIENT HAS DOCUMENTED HYPERSENSITIVITY TO NICKEL, THE STARCLOSE SE DEVICE CLIP WAS USED TO SUCCESSFULLY ACHIEVE HEMOSTASIS. THE PATIENT HAS NOT DEVELOPED ANY SIGNS OR SYMPTOMS RELATED TO THE IMPLANTATION OF THE STARCLOSE SE DEVICE CLIP. THE PHYSICIAN WAS REPORTED TO BE 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
    183635 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other SHEATH: 6-FRENCH HEPARIN