BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRODUCER, CATHETR

    MDR report key: 17532525 · Received August 12, 2023

    Report

    Report Number
    MW5139433
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    August 10, 2012
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    TECHNICAL SERVICES RECEIVED, A CALL ON 07/03/2012 FROM SALES REP. REP CALLED TO DISCUSS THE USAGE OF A SJM 9FR INTRODUCER. THEY HAD DIFFICULTY, PASSING THROUGH THIS 9FR AND USED A 10.5FR. DISCUSSED THAT INTRODUCE RS DO HAVE DIFFERENT TOLERANCES. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049553 INTRODUCER, CATHETR INTRODUCER, CATHETER DYB ST. JUDE MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown