BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿

    MDR report key: 22320728 · Received June 24, 2025

    Report

    Report Number
    3005334138-2025-00381
    Event Type
    Malfunction
    Date Received
    June 24, 2025
    Date of Event
    June 17, 2025
    Report Date
    September 19, 2025
    Manufacturer
    ABBOTT MEDICAL (AFD-PLYMOUTH)
    Product Code
    DRF
    UDI-DI
    05415067028198
    PMA / PMN Number
    K202066
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H2, H3, H6. ONE BI-DIRECTIONAL, CURVE D-F, SENSOR ENABLED, ADVISOR HD GRID MAPPING CATHETER WAS RECEIVED FOR EVALUATION. THE DISTAL COUPLER WAS NOTED TO BE DISPLACED AND THE PELLETHANE TUBING WAS WRINKLED WITH BLS OBSERVED COVERING THE PADDLE. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. INFORMATION FROM THE FIELD INDICATED THAT THE USE OF FORCE WAS ATTEMPTED IN THE REMOVING OF THE CATHETER. THE ADVISOR HD GRID SE CATHETER INSTRUCTIONS FOR USE (IFU) STATES, "DO NOT USE FORCE TO ADVANCE OR WITHDRAW CATHETER WHEN RESISTANCE IS ENCOUNTERED." THE CAUSE OF THE PADDLE DAMAGE AND REPORTED REMOVAL ISSUE IS CONSISTENT WITH NOT FOLLOWING THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 0

    DURING A PAC CASE, HDGRID WAS USED TO MAP. AFTER FINISHING POINTS COLLECTION, WHEN THE PHYSICIAN TRIED TO TAKE OUT OF THE PATIENT THE HDG CATHETER, IT WAS STUCK AT THE INTRODUCER LEVEL (IT WAS A SMALL INTRODUCER, 9 FR, IN FEMORAL VEIN, CORDIS). SEVERAL ATTEMPTS WERE DONE TO TAKE THE CATHETER OUT BUT WITHOUT SUCCESS. THEN, PHYSICIAN TOOK OUT THE 9FR INTRODUCER BUT THE CATHETER REMAINED INSIDE THE VEIN. DIFFERENT MANEUVERS WERE DONE TO REMOVE THE CATHETER BUT WITHOUT SUCCESS. FINALLY, THE PHYSICIAN DECIDED TO REMOVE FROM THE VEIN ALL THE OTHER INTRODUCERS AND AFTER DOING THIS, THE HDGRID GOT OUT FROM THE PATIENT SMOOTHLY WITHOUT ANY EFFORT. PROCEDURE WAS INTERRUPTED AND ABLATION WAS POSTPONED. NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2063921 ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿ CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF ABBOTT MEDICAL (AFD-PLYMOUTH) D-AVHD-DF16 10368895 05415067028198

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown