BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER

    MDR report key: 2481395 · Received March 1, 2012

    Report

    Report Number
    MW5024519
    Event Type
    Malfunction
    Date Received
    March 1, 2012
    Date of Event
    February 28, 2012
    Report Date
    March 1, 2012
    Manufacturer
    MEDTRONIC AVE
    Product Code
    JCY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A 6F SHERPA BAL EBU3.5 CATHETER WOULD NOT PASS THROUGH THE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHETER 6F SHERPA BAL EBU3.5 CATHETER JCY MEDTRONIC AVE 0005925870

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR