BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1923700 · Received December 9, 2010

    Report

    Report Number
    3003681312-2010-00077
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    November 11, 2010
    Report Date
    December 9, 2010
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. 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 OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES THAT BLEEDING OR A HEMATOMA AT THE PUNCTURE SITE IS A POSSIBLE RISK OR SITUATION THAT MAY BE ASSOCIATED WITH THE USE OF THE DEVICE OR VASCULAR ACCESS PROCEDURES. IF THIS SHOULD OCCUR, THE IFU INSTRUCTS THE USER TO APPLY DIGITAL OR MANUAL PRESSURE TO THE PUNCTURE SITE AND IF NECESSARY, MONITOR PEDAL PULSES. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) CAUTIONS, 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 AN ANGIO-SEAL WAS DEPLOYED IN THE RIGHT FEMORAL ARTERIOTOMY. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. HEMOSTASIS WAS NOT ACHIEVED AND MANUAL PRESSURE WAS HELD. PEDAL PULSES DIMINISHED AND THE PATIENT WAS TAKEN TO SURGERY WHERE A RIGHT FEMORAL THROMBOEMBOLECTOMY WAS PERFORMED. THE ANGIO-SEAL WAS REMOVED. THE PATIENT'S EXTERNAL ILIAC ARTERY HAD BEEN PLACED. THE PATIENT IS REPORTED TO BE STABLE. THE PATIENT WAS GIVEN 75MG OF PLAVIX AND 81MG OF ASPIRIN DURING THE CATHETERIZATION. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL DEVICE MGB ST. JUDE MEDICAL PUERTO RICO, B.V. NA 3146364

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R