BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDDICK CHOLANGIOGRAM CATHETER

    MDR report key: 1082516 · Received July 25, 2008

    Report

    Report Number
    1220948-2008-00005
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    May 27, 2008
    Report Date
    June 10, 2008
    Manufacturer
    LEMAITRE VASCULAR
    Product Code
    GBZ
    PMA / PMN Number
    K030041
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON JUNE 20TH, 2008 A MEDWATCH 3005A FORM WAS RECEIVED BY LEMAITRE VASCULAR FROM THE MEDICAL FACILITY. AFTER CORRESPONDENCE WITH THE FACILITY REP, IT BECAME CLEAR THAT DURING PROCEDURE, THE PHYSICIAN WAS UNABLE TO INSERT THE CATHETER INTO THE INTRODUCER. ANOTHER REDDICK CHOLANGIOGRAM CATHETER FROM ANOTHER LOT WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. THE PT IS IN GOOD CONDITION. WHEN ASSESSING THE COMPLAINT RISK, WE DO NOT FEEL THIS IS A REPORTABLE MDR AS IT APPEARS TO BE A USER INCONVENIENCE. THE DEVICE IS IN TRANSIT FOR EVAL PURPOSES. FROM THE EVAL, IF WE FEEL THAT IT SHOWS ANYTHING ELSE BESIDES A USER INCONVENIENCE, A FOLLOW-UP REPORT WILL BE SENT. IF NOT, WE WILL CONSIDER THIS MEDWATCH FILE TO BE CLOSED, AND HANDLED THROUGH OUR COMPLAINT PROGRAM.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT SUBMITTED BY THE HOSPITAL SENT TO US FROM THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REDDICK CHOLANGIOGRAM CATHETER REDDICK GBZ LEMAITRE VASCULAR 2401-52 RST 1292

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR