BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS INTRODUCER II KIT

    MDR report key: 375883 · Received February 8, 2002

    Report

    Report Number
    1118880-2002-00002
    Event Type
    Injury
    Date Received
    February 8, 2002
    Date of Event
    December 9, 2001
    Report Date
    January 10, 2002
    Manufacturer
    TERUMO MEDICAL CORP
    Product Code
    DYB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PTCA PROCEDURE, THERE WAS TWISTING OF THE CATHETER IN THE INTRODUCER SHEATH. THE CATHETER COULD NOT BE REMOVED THROUGH THE SHEATH, SO THE SHEATH AND CATHETER WERE REMOVED TOGETHER. A NEW SHEATH WAS THEN PLACED, BUT OOZING FROM THE VESSEL WAS NOTED ON ANGIOGRAPHY WITH FORMATION OF A HEMATOMA. THE PT WAS TRANSFERRED TO CV-ICU FOR C-CLAMP TO THE GROIN UNTIL HEMOSTASIS WAS MAINTAINED. THE PT WAS DESCRIBED AS HAVING NO NEGATIVE OUTCOMES TO THIS EVENT. THIS EVENT WAS REPORTED IN RELATION TO THE GUIDING CATHETER DEVICE BY THE USER FACILITY (MEDWATCH UF/DIST REPORT # 1023162) AND THE GUIDING CATHETER MFR (MFR# 6000093-2001-00095).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIFOCUS INTRODUCER II KIT INTRODUCER KITS DYB TERUMO MEDICAL CORP NA AF14

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention WISEGUIDE CORONARY GUIDING CATHETER.