BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTARAY NAV

    MDR report key: 21905615 · Received April 24, 2025

    Report

    Report Number
    2029046-2025-01321
    Event Type
    Malfunction
    Date Received
    April 24, 2025
    Date of Event
    October 24, 2024
    Report Date
    April 24, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835012255
    PMA / PMN Number
    K123837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION DETAILS. THE PRODUCT WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J) FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED FOLLOWING JOHNSON & JOHNSON MEDTECH PROCEDURES. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT TWO SPLINES WERE BROKEN WITH EXPOSED WIRES. ALSO, FOREIGN MATERIAL WAS OBSERVED ON TWO ELECTRODES. THE BROKEN SPLINES CONDITION NOTED DURING THE ANALYSIS COULD BE RELATED TO THE CUSTOMER COMPLAINT REGARDING THAT THE DEVICE WAS RECOGNIZED BY THE CARTO BUT ITS BRANCHES WERE NOT VISUALIZED ON THE CARTO SYSTEM. DUE TO THE FOREIGN MATERIAL, A TRANSFORM INFRARED SPECTROSCOPY (FT-IR) ANALYSIS WAS PERFORMED. THE FT-IR ANALYSIS CONCLUDED THAT THE UNKNOWN MATERIAL PRESENTED AN INFRARED SPECTRUM CHARACTERISTIC OF BIOLOGICAL-BASED SUBSTANCES, POTENTIALLY INDICATING THE PRESENCE OF TISSUE. THESE FINDINGS SUGGEST THAT ORIGIN OF UNKNOWN MATERIAL IS RELATED TO THE MEDICAL PROCEDURE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE VISUALIZATION ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED DUE TO CONDITIONS IN WHICH THE DEVICE WAS RETURNED; HOWEVER, THE EXACT TIME WHEN THE SPLINES WERE DETACHED FROM THE REST OF THE DEVICE, COULD NOT BE DETERMINED AT THIS TIME. IT COULD BE RELATED TO THE HANDLING OF THE DEVICE AFTER PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THE BIOLOGICAL MATERIAL FOUND ON THE ELECTRODES OF THE DEVICE COULD BE RELATED TO THE PROCEDURE; AND IT IS NOT RELATED TO THE CUSTOMER COMPLAINT. THE INSTRUCTION FOR USE (IFU) STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. DO NOT USE EXCESSIVE FORCE TO ADVANCE OR WITHDRAW THE CATHETER THROUGH THE GUIDING SHEATH WHEN RESISTANCE IS ENCOUNTERED. AS PART OF THE JOHNSON & JOHNSON MEDTECH QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH A PENTARAY NAV FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED 2 BROKEN SPLINES WITH EXPOSED WIRES. INITIALLY IT WAS REPORTED THAT THERE WAS A VISUALIZATION ISSUE. DURING THE PROCEDURE, THE DEVICE WAS RECOGNIZED BY THE CARTO BUT ITS BRANCHES WERE NOT VISUALIZED ON THE CARTO SYSTEM. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. AFTERWARD, THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. ADDITIONAL INFORMATION WAS THEN REQUESTED TO CLARIFY IF THE RETURNED CONDITION OF "2 BROKEN SPLINES WITH EXPOSED WIRES" OCCURRED DURING OR POST PROCEDURE AS IT WAS NOT ORIGINALLY REPORTED. HOWEVER, RESPONSE STATED IT WAS UNKNOWN. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, THE 2 BROKEN SPLINES WITH EXPOSED WIRES WERE ASSESSED AS MDR REPORTABLE AS OF 31-JAN-2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1226365 PENTARAY NAV CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31389924L 10846835012255

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNK_CARTO 3