BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE

    MDR report key: 1131994 · Received August 21, 2008

    Report

    Report Number
    3003681312-2008-00077
    Event Type
    Injury
    Date Received
    August 21, 2008
    Report Date
    July 24, 2008
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED; THEREFORE, AN EVAL COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO PROVIDED TO ST JUDE MEDICAL, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL INSTRUCTION FOR USE (IFU) STATES SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), AN ANGIO-SEAL WAS DEPLOYED AND HEMOSTASIS WAS ACHIEVED. THE PT WAS DOING FINE FOR EIGHT DAYS. ON THE NINTH DAY, THE PT REPORTED TO THE HOSPITAL WITH LEG PAIN. THE SURGEON FOUND PART OF THE ANCHOR AND THROMBOSIS IN THE POPLITEAL ARTERY. THE PT WAS REPORTED IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE ANGIO-SEAL VIP MGB ST. JUDE MEDICAL PUERTO RICO, B.V. NA 2076373

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention