BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER

    MDR report key: 20745325 · Received November 21, 2024

    Report

    Report Number
    20745325
    Event Type
    Malfunction
    Date Received
    November 21, 2024
    Date of Event
    August 8, 2024
    Report Date
    August 20, 2024
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    NLH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    ELECTROPHYSIOLOGY (EP) LAB HAS EXPERIENCED A PROBLEM WITH DEVICE FAILURE WITH OUR REPROCESSED CATHETERS FROM STRYKER. IN THIS INSTANCE THE HUB OF THE CATHETER BROKE APART WHEN ATTEMPTING TO PULL THE CATHETER OUT FROM THE PROTECTIVE SHEATH. LEAD NURSE IN THE EP LAB BELIEVES THAT THE ISSUE IS NOT WITH ABBOTT, BUT THEY BELIEVE IT RELATES TO REPROCESSING OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1999839 CATHETER CATHETER, RECORDING, ELECTRODE, REPROCESSED NLH STRYKER SUSTAINABILITY SOLUTIONS 401880 5369922

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Female