BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS

    MDR report key: 513451 · Received March 1, 2004

    Report

    Report Number
    2182269-2004-00020
    Event Type
    Injury
    Date Received
    March 1, 2004
    Date of Event
    January 31, 2004
    Manufacturer
    ST. JUDE MEDICAL, DAIG DIVISION, INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION FOLLOWED BY DEPLOYMENT OF AN ANGIO-SEAL DEVICE. HEMOSTASIS WAS NOT ACHIEVED. A C-CLAMP WAS APPLIED TO ACHIEVE HEMOSTASIS. THE FOLLOWING DAY, THE PT COMPLAINED OF PAIN IN THE LEG OF THE PREVIOUS ACCESS SITE; THE PEDIAL PULSE WAS DIMINISHED. AN EMBOLECTOMY WAS PERFORMED. THE ANGIO-SEAL DEVICE ANCHOR, COLLAGEN, AND REMAINING SUTURE WERE RETRIEVED USING A SNARE FROM A VESSEL BELOW THE LEVEL OF THE KNEE. NORMAL BLOOD FLOW WAS ESTABLISHED AND THERE WERE NO FURTHER COMPLICATIONS; THE PT WAS DISCHARGED FOLLOWING THE PROCEDURE. THE PT WAS REPORTEDLY RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS 8F ANGIO-SEAL STS MGB ST. JUDE MEDICAL, DAIG DIVISION, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention