BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 2834290 · Received November 15, 2012

    Report

    Report Number
    2024168-2012-07218
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    April 1, 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
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO PRODUCT DEFICIENCY AND 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. ESTIMATED DATE OF EVENT - THE CUSTOMER REPORTED THE PRODUCT EXPERIENCE OCCURRED AFTER A CATHETERIZATION PROCEDURE IN (B)(6) 2011.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED VIA AN INTERNET BLOG POSTING (ANGIOPLASTY.ORG) REGARDING A STARCLOSE DEVICE. THE PATIENT WROTE "(B)(6) 2011' UNDERWENT A CATH, WAS NOT TOLD ABOUT THE 'STAR CLOSURE' TIL AFTER THE PROCEDURE. IF I HAD BEEN TOLD I WOULD HAVE TOLD THEM NO, AS WHEN I WAS YOUNGER I HAD TROUBLE WITH IUD'S [INTRAUTERINE DEVICE], SO I KNOW I HAVE NO TOLERANCE TO METAL NO MATTER HOW SMALL. ANYWAYS SINCE THE PROCEDURE IF ON MY FEET TOO LONG OR I AM VERY ACTIVE I GET A TERRIBLE CRAMP LIKE FEELING IN THE GROIN AREA, TO THE POINT I HAVE A PRONOUNCED LIMP. WENT BACK TO MY SURGEON, THEY DID ON ULTRA SOUND AND REFERRED ME BACK TO MY REG DR. THEY ARE STATING THAT IT IS NOT FROM THE CLIP THEY USED MUST BE RELATED TO SOMETHING ELSE.' THE PATIENT INDICATED THAT SHE HAD A 'HARD TIME BELIEVING THAT.' ADDITIONALLY, THE PATIENT BELIEVED THAT PHYSICIANS 'NEED TO INFORM THEIR PATIENTS BEFORE THE CATH ABOUT WHAT THEY ARE DOING AND LEAVING IN YOUR BODIES. THIS NEW CONDITION IS A TERRIBLE THING NOT ONLY AM I ACTIVE BUT I AM A WAITRESS /BARTENDER SO IT IS INTERFERING WITH MY JOB.' 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