BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 517917 · Received March 26, 2004

    Report

    Report Number
    2182269-2004-00058
    Event Type
    Injury
    Date Received
    March 26, 2004
    Date of Event
    January 28, 2004
    Report Date
    March 26, 2004
    Manufacturer
    ST. JUDE MEDICAL, DAIG DIVISION, INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN ANGIO-SEAL DEVICE WAS DEPLOYED TO SEAL THE PUNCTURE SITE WITHOUT COMPLICATIONS. THE PT COMPLAINED OF LEG PAIN (TIME UNKNOWN). THE PT WAS DISCHARGED THE FOLLOWING DAY. A FOLLOW-UP APPOINTMENT REVEALED THE LEG WAS STILL PAINFUL AND DECREASED PULSES WERE NOTED. THE PT UNDERWENT PERCUTANEOUS INTERVENTION (ANGIOJET) WITH THROMBOLYTICS; BLOODFLOW WAS RESTORED, THE PHYSICIAN STATED HE REMOVED COLLAGEN FROM THE VESSEL. THE PT WAS RELEASED FROM THE HOSPITAL WITH GOOD PULSES (TIME UNKNOWN). THE PT WAS REPORTEDLY RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS 6F ANGIO-SEAL STS PULS MGB ST. JUDE MEDICAL, DAIG DIVISION, INC. NA 1052616

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention THROMBOLYTIC INFUSION, DATE AND DOSAGE UNKNOWN.