BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMAFLEX PTCA SHEATH KIT

    MDR report key: 15419 · Received January 10, 1994

    Report

    Report Number
    15419
    Event Type
    Injury
    Date Received
    January 10, 1994
    Date of Event
    December 22, 1993
    Report Date
    December 22, 1993
    Manufacturer
    BARD, INCORPORATED
    Product Code
    EYT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CATHETERIZATION PROCEDURE, A PCTA ARTERIAL SHEATH DISONNECTED AND REMAINED IN RIGHT FEMORL ARTERY.PATIENT TAKEN TO OPERATING ROOM FOR REMOVAL OF SHEATH ON 12/22/93.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMAFLEX PTCA SHEATH KIT Implant EYT BARD, INCORPORATED N/A 09FD0177

    Patients

    Seq Age Sex Outcome Treatment
    1 73 * Required Intervention