BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2822740 · Received November 7, 2012

    Report

    Report Number
    2024168-2012-07005
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 24, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 CANNOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE, WITH A 6FR SHEATH, AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN DEPLOYING THE CLIP, IT WAS NOTICED THAT THE CLIP LOOKED LIKE IT WAS ANCHORED AT THE END OF THE DELIVERY SYSTEM. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 20514K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6FRHEPARIN