BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOSEAL

    MDR report key: 2020652 · Received March 10, 2011

    Report

    Report Number
    2020652
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 10, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    DISTAL LEFT SUPERFICIAL FEMORAL ARTERY STENOSIS ANGIOPLASTY WAS PERFORMED. AN ANGIOSEAL DEVICE WAS DEPLOYED, WITH INABILITY TO ADVANCE OR ACHIEVE HEMOSTASIS. PRESSURE WAS APPLIED FOR ABOUT FIVE (5) MINUTES WITH HEMOSTASIS ACHIEVED. THE PATIENT'S LEFT TOE WAS NOTED TO BE SLIGHTLY CYANOTIC, ALTHOUGH HE WAS NOT COMPLAINING OF ANY SYMPTOMS. HE HAD FULL MOTOR FUNCTION AND SENSATION. NO DOPPLER PULSE IN THE LEFT FOOT. REPEAT ANGIOGRAM SHOWED AN OCCLUSION OF THE MID TO DISTAL LEFT COMMON FEMORAL ARTERY THE SAME LOCATION OF THE ORIGINAL LEFT ANTEGRADE PUNCTURE. PROCEDURE COMPLICATED BY OCCLUSION OF THE LEFT COMMON FEMORAL ARTERY AS A RESULT OF THE ANGIO-SEAL DEVICE. THE PATIENT WAS GIVEN A SECOND 3000 UNIT HEPARIN BOLUS. WEIGHT-BASED HEPARIN INFUSION STARTED. VASCULAR SURGERY TOOK THE PATIENT TO THE OR THE NEXT DAY FOR FOR RETAINED FOREIGN BODY (RFB) REMOVAL. PATIENT DISCHARGED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOSEAL DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL 610119 3244209

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR OTHER