BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 2834414 · Received November 15, 2012

    Report

    Report Number
    2024168-2012-07225
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 15, 2011
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 (ANGIOPLASTY.ORG) REGARDING A STARCLOSE DEVICE. THE PATIENT WROTE "ON (B)(6) 2011, I HAD AN AORTIC ARCH ANGIOGRAM WHICH USED THE STARCLOSE CLOSURE DEVICE. I HAD A QUICK RECOVERY WITH NO PROBLEMS. BUT, TWO WEEKS AGO, I JOINED A GYM AND STARTED EXERCISING WITH WEIGHTS. THIS WEEK I NOTICE PAIN AT THE AREA WHERE THE STARCLOSE IS LOCATED. IT IS A DIFFERENT PAIN THAT THE NORMAL PAIN OF SORE MUSCLES." 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