BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 3932075 · Received June 20, 2014

    Report

    Report Number
    3003681312-2014-00049
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    March 2, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MFG AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECS AND PROCEDURES. BASED ON THE INFO RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    THE INFO PROVIDED TO SJM INDICATED THE 6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE WAS SELECTED FOR USE FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION (PCI) IN THE RIGHT FEMORAL ARTERY. A PRE-DEPLOYMENT ANGIOGRAM HAD BEEN PERFORMED PRIOR TO THE PROCEDURE. CLOPIDOGREL (600MG) WAS ADMINISTERED DURING THE PROCEDURE AND AGAIN ONE DAY POST-DEPLOYMENT. TWO DAYS POST-DEPLOYMENT A PSEUDOANEURYSM WAS DETECTED ON ULTRASOUND. THE PT UNDERWENT 40 MINUTES OF ULTRASOUND GUIDED MANUAL COMPRESSION AND A THROMBIN INJECTION THE FOLLOWING DAY. THE PT WAS DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362413 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL 610132 4193918

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R