BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLANAV MIFI OPEN-IRRIGATED

    MDR report key: 11878420 · Received May 25, 2021

    Report

    Report Number
    2134265-2021-06758
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Date of Event
    April 30, 2021
    Report Date
    July 9, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OAD
    UDI-DI
    08714729938378
    PMA / PMN Number
    P150005/S017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE CATHETER WAS RECEIVED AT BOSTON SCIENTIFIC'S POST MARKET LABORATORY FOR EXAMINATION. UPON RECEIPT VISUAL INSPECTION FOUND THE MAIN SHAFT TUBING WAS KINKED AND TORN OPEN NEAR THE BUTT BOND. WHEN EXAMINED UNDER X-RAY IT WAS FOUND THE MAGNETIC SENSOR WIRE WAS KINKED AND THE GUIDE COIL HAD COLLAPSED. THERE WAS EVIDENCE OF FLUID INGRESS AT THE SITE OF THE FRACTURE. NEXT THE FUNCTION OF THE CATHETER'S CURVE WAS TESTED, FINDING THAT THE LEFT CURVE FAILED TO REACH THE FULL CURVE. WHEN THE STEERING KNOB AND TENSION CONTROL WERE TESTED THEY WERE FOUND TO FUNCTION PROPERLY AND NO ABNORMAL RESISTANCE WAS FOUND. THEN THE CATHETER WAS TESTED ELECTRICALLY, AND ALL ELECTRODE AND THERMOCOUPLE MEASUREMENTS WERE FOUND TO BE IN SPECIFICATIONS. THIS WAS ALSO THE CASE WHEN THE TESTS WERE REPEATED WITH THE CATHETER IN BOTH THE RIGHT AND LEFT CURVE CONFIGURATIONS. FINALLY THE CATHETER WAS PRESSURE TESTED FOR LEAKS AND IT WAS FOUND THE PRESSURE DECAY VALUES WERE WITHIN THE ACCEPTABLE LIMIT. THE REPORTED ALLEGATION WAS CONFIRMED THROUGH DEVICE ANALYSIS. THE MAIN SHAFT WAS SEVERELY KINKED WHICH CAUSED A BREACH IN THE OUTER LAYER OF THE CATHETER SHAFT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE USING AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER THEY HAD DIFFICULTY DEFLECTING THE CATHETER AND WHEN THEY REMOVED THE CATHETER TO EXAMINE IT THEY FOUND THE OUTER COVERING OF THE CATHETER WAS COMPROMISED. THEY REPLACED THE CATHETER AND WERE ABLE TO COMPLETE THE PROCEDURE WITHOUT ANY PATIENT COMPLICATIONS. THE CATHETER HAS BEEN RECEIVED AT BOSTON SCIENTIFIC FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE USING AN INTELLANAV MIFI OPEN-IRRIGATED CATHETER THEY HAD DIFFICULTY DEFLECTING THE CATHETER AND WHEN THEY REMOVED THE CATHETER TO EXAMINE IT THEY FOUND THE OUTER COVERING OF THE CATHETER WAS COMPROMISED. THEY REPLACED THE CATHETER AND WERE ABLE TO COMPLETE THE PROCEDURE WITHOUT ANY PATIENT COMPLICATIONS. THE CATHETER HAS BEEN RECEIVED AT BOSTON SCIENTIFIC AND IS AWAITING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775667 INTELLANAV MIFI OPEN-IRRIGATED CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BOSTON SCIENTIFIC CORPORATION 87047 0026369941 08714729938378

    Patients

    Seq Age Sex Outcome Treatment
    1