BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOSTATIC PUNCTURE CLOSURE DEVICE

    MDR report key: 245145 · Received October 8, 1999

    Report

    Report Number
    245145
    Event Type
    Injury
    Date Received
    October 8, 1999
    Date of Event
    September 2, 1999
    Report Date
    October 7, 1999
    Manufacturer
    DAIG CORP. ST JUDE MEDICAL SC, INC., DAIG DIV.
    Product Code
    MGB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT HEART CATH W/ PLACEMENT OF AN ANGIOSEAL INTO RT FEMORAL ARTERY. ABNORMAL BLEEDING WAS NOTED AT SITE AND AROUND THE TAMPER TUBE. DISTAL PULSES GREATLY DIMINISHED THEN ABSENT RT FOOT/LEG. SURGERY FOLLOWED W/ REMOVAL OF PLUG; PULSES OF RT FOOT/LEG RETURNED. DISCHARGED 9/3/1999. TWO FOLLOW-UP CALLS "PROBLEM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOSTATIC PUNCTURE CLOSURE DEVICE Implant HEMOSTATIC PUNCTURE CLOSURE DEVICE MGB DAIG CORP. ST JUDE MEDICAL SC, INC., DAIG DIV. * 104713

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention