BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿

    MDR report key: 14518234 · Received May 26, 2022

    Report

    Report Number
    3008452825-2022-00441
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Date of Event
    May 18, 2022
    Report Date
    September 20, 2022
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DRF
    UDI-DI
    05415067028198
    PMA / PMN Number
    K172393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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 ENTANGLEMENT REMAINS UNKNOWN.

    Description of Event or Problem · 0

    RELATED MANUFACTURING REF: 3008452825-2022-00442. DURING THE PROCEDURE, THE CATHETERS BECAME ENTANGLED WITH EACH OTHER. WHILE MAPPING IN THE RIGHT ATRIUM, THE HD GRID CATHETER WENT INTO THE RIGHT VENTRICLE (RV) AND THE RV CATHETER (JSN) WENT THROUGH THE OPENING BETWEEN THE SPLINES OF THE HD GRID CATHETER. THE PHYSICIAN WAS UNAWARE THAT THE RV CATHETER WENT THROUGH THE SPLINES AND PULLED THE HD GRID CATHETER BACK INTO THE SRO SHEATH TO REMOVE IT. WHEN DOING SO, THE JSN CATHETER WAS PULLED INTO THE SHEATH AND PULLED HARDER TO REMOVE HD GRID. FLUOROSCOPY REVEALED THE JSN CATHETER WAS DOUBLED OVER AND STICKING OUT OF THE TOP OF THE SRO SHEATH. BOTH CATHETERS WERE STUCK IN THE SHEATH. TECH SERVICES WAS CONTACTED AND WHILE ON THE PHONE, THE PHYSICIAN PUSHED AND THE TWO CATHETERS FINALLY CAME OUT THE DISTAL END OF THE SRO AND WAS ABLE TO REMOVE THE JSN, THEN THE GRID. BOTH CATHETERS WERE INTACT, BUT BENT. THERE WAS NO HARM TO THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1502434 ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿ CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF ST. JUDE MEDICAL D-AVHD-DF16 8313147 05415067028198

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SUPREME¿ EP CATHETER