BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1140996 · Received August 27, 2008

    Report

    Report Number
    3003681312-2008-00087
    Event Type
    Injury
    Date Received
    August 27, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 27, 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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED; THEREFORE, AN EVALUATION COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFORMATION 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 A 6F ANGIO-SEAL WAS DEPLOYED IN THE RIGHT FEMORAL ARTERY; HEMOSTASIS WAS ACHIEVED. THE NEXT DAY, THE PATIENT FELT PAIN IN THE LEG WHILE BEING TRANSFERRED TO THE NURSING FLOOR. THE PATIENT'S LEG WAS COLD AND WHITE IN COLOR DURING EXAMINATION. THE PATIENT WAS TAKEN TO SURGERY TO REMOVE THE ANGIO-SEAL. THE PATIENT HAS RECOVERED AND WAS REPORTED IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL VIP MGB ST. JUDE MEDICAL, PUERTO RICO, B.V. NA 2152750

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention