BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 2834311 · Received November 15, 2012

    Report

    Report Number
    2024168-2012-07220
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    March 3, 2012
    Report Date
    October 23, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED VIA AN INTERNET BLOG POSTING ((B)(4)) REGARDING A STARCLOSE DEVICE. THE PATIENT WROTE "I WAS IN A MOTORCYCLE ACCIDENT IN (B)(6) ON (B)(6) 2012 AND WAS ADMITTED TO THE HOSPITAL FOR SEVERE BRUISING AND ALSO HAD SOME INTERNAL BLEEDING ON MY LEFT HIP. THE DOCTORS CHOSE STAR CLOSE TO FIX THE BLEEDING. THEY WENT IN THROUGH THE RIGHT GROIN. I LEFT VEGAS AND FLEW HOME TO COLD LAKE ALBERTA ON (B)(6). I WAS OFF WORK UNTIL (B)(6) BUT WENT BACK WITH STILL SOME PAIN. THE BRUISING HAS SUBSIDED BUT I AM STILL HAVING SHARP PAIN IN MY LEFT HIP. IS THIS NORMAL? THE ENTRANCE AREA FROM THE STAR CLOSURE IS NOT A PROBLEM AT ALL. THAT HEALED WELL. IT JUST SEEMS TO BE THE AREA WHERE I ASSUME THE BLEED WAS. A LOT OF THE PAIN IS IN THE FATTY PART OF MY HIP AND IN THE JOINT/OR LEG CREASE." THERE WAS NO ALLEGATION THAT THE STARCLOSE DEVICE MALFUNCTIONED OR DID NOT ACHIEVE HEMOSTASIS. THE OPERATOR IS NOT KNOWN; THEREFORE, IT IS NOT KNOWN IF THE OPERATOR IS 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
    1 STARCLOSE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other