BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿

    MDR report key: 19140997 · Received April 18, 2024

    Report

    Report Number
    3008452825-2024-00230
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Date of Event
    April 4, 2024
    Report Date
    June 5, 2024
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DRF
    UDI-DI
    05415067028198
    PMA / PMN Number
    K202066
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THE INCORRECT LOT NUMBER WAS ORIGINALLY PROVIDED. THE CORRECT LOT NUMBER OF THE COMPLAINT DEVICE IS 8981801. ADDITIONALLY, THE MANUFACTURER OF LOT NUMBER 8981801 IS PLYMOUTH MFR 3005334138.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H2, H3, H6, H11. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED COMMUNICATION ISSUE AND SUBSEQUENT DELAY COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    DURING AN ATRIAL TACHYCARDIA PROCEDURE, THERE WAS A COMMUNICATION ISSUE WITH THE ADVISOR HD MAPPING CATHETER RESULTING IN A DELAY. AN ERROR MESSAGE APPEARED ON THE ENSITE X SYSTEM THAT READ, "CATHETER IN PORT 4 IS INVALID BECAUSE IT HAS ALREADY BEEN USED WITH A DIFFERENT PATIENT. DISCONNECT IT AND TRY ANOTHER CATHETER.¿ DESPITE USING A NEW CATHETER. THE CONNECTER WAS CHANGED, THE AMPLIFIER AND ENSITE X DWS WERE RESTARTED, BUT THE ISSUE PERSISTED. THE ADVISOR HD MAPPING CATHETER WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1822799 ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿ CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF ST. JUDE MEDICAL D-AVHD-DF16 8981801 05415067028198

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown