BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 3883721 · Received June 6, 2014

    Report

    Report Number
    3003681312-2014-00040
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 13, 2014
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LG
    Reporter Occupation
    PHYSICIAN

    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 MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATION AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    AN 8F ANGIO-SEAL STS PLUS WAS SELECTED FOR USE ON THE COMMON FEMORAL ARTERIOTOMY FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED AND HEMOSTASIS WAS ACHIEVED WITHOUT INCIDENT. EIGHT HOURS LATER, A HEMATOMA DEVELOPED AND WAS TREATED USING BEDREST WITH AN ICE PACK FOR EIGHT HOURS. THE PT WAS DISCHARGED. TWO DAYS FOLLOWING THE PROCEDURE, THE PT RETURNED TO THE HOSPITAL PRESENTING WITH INFLAMMATION WITH A MODERATE LYMPHATIC REACTION. THE PT WAS GIVEN A BROAD-SPECTRUM ANTIBIOTIC. THE PT IS CURRENTLY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331219 8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL 610122 4325837

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R