BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿

    MDR report key: 12882104 · Received November 29, 2021

    Report

    Report Number
    3005334138-2021-00760
    Event Type
    Malfunction
    Date Received
    November 29, 2021
    Date of Event
    November 5, 2021
    Report Date
    December 6, 2021
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DRF
    UDI-DI
    05415067028198
    PMA / PMN Number
    K172393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    MANUFACTURER REPORT NUMBER: 3005334138-2021-00759. DURING DEVICE PREPARATION FOR A PREMATURE VENTRICULAR CONTRACTION PROCEDURE (PVC) THE ADVISOR HD GRID WAS CONNECTED TO THE AMPLIFIER VIA A DIRECT CONNECT CABLE OUTSIDE THE PATIENT, BUT THE "HDG @ 4" AND GREEN CIRCLE, WHICH WAS DISPLAYED WHEN THE CATHETER WAS CONNECTED, WAS NOT DISPLAYED AT THE BOTTOM RIGHT OF THE MAIN SCREEN. WHEN THE CATHETER SETTING SCREEN WAS CONFIRMED, IT SEEMED THAT IT WAS RECOGNIZED AS CATHETER, BUT NOT RECOGNIZED AS SE CATHETER. THE CATHETER WAS EXCHANGED WITH NO RESOLUTION. THE PROCEDURE PROGRESSED, WHEN THE DEVICE WAS INSERTED, THE "HDG @ 4" AND GREEN CIRCLE WAS DISPLAYED AT THE BOTTOM RIGHT OF THE SCREEN. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE HOSPITAL DISCARDED THE REPORTED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1781689 ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿ CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF ST. JUDE MEDICAL D-AVHD-DF16 8063192 05415067028198

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ADVISOR HD