BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTARAY MAPPING CATHETER

    MDR report key: 23583751 · Received November 18, 2025

    Report

    Report Number
    2029046-2025-03827
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    October 21, 2025
    Report Date
    November 18, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835021127
    PMA / PMN Number
    K193237
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER, AND THE CATHETER STOPPED IRRIGATING PROPERLY AFTER IT WAS REMOVED FROM THE BODY. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION AND IRRIGATION TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL INSPECTION REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. AN IRRIGATION TEST WAS PERFORMED, AND THE DEVICE WAS IRRIGATING CORRECTLY, NO OBSTRUCTED HOLE WAS OBSERVED. NO IRRIGATION ISSUES WERE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. THE IRRIGATION ISSUE REPORTED BY THE CUSTOMER COULD NOT BE REPLICATED DURING THE PRODUCT INVESTIGATION; OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USE OF THE DEVICE THAT MAY HAVE AFFECTED ITS PERFORMANCE. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING INFORMATION: FLUSH THE CATHETER WITH HEPARINIZED NORMAL SALINE PRIOR TO INSERTION INTO THE BODY AND ENSURE THAT SALINE FLOWS THROUGH THE DISTAL END OF THE IRRIGATION LUMEN. AS PART OF JOHNSON & JOHNSON MEDTECH'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER, AND THE CATHETER STOPPED IRRIGATING PROPERLY. IT WAS REPORTED THAT THE OCTARAY MAPPING CATHETER STOPPED IRRIGATING PROPERLY AFTER IT WAS REMOVED FROM THE BODY. WHEN THEY ATTEMPTED TO FLUSH THE CATHETER, THEY NOTICED IT WAS DRIPPING VERY LITTLE FLUID. WHEN THE CATHETER WAS REPLACED, THE ISSUE RESOLVED. REPLACEMENT CATHETER REQUESTED. THE CATHETER WAS BRAND NEW AND NOT REPROCESSED. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE ISSUE WAS NOT NOTED BEFORE THE DEVICE WAS USED ON PATIENT. THE CATHETER WAS CONNECTED TO A FLUSH LINE AND WAS NOT CONNECTED TO A PUMP. THE PHYSICIAN NOTED THAT IT WAS NOT FLUSHING PROPERLY, AND NO ERROR WAS NOTED FROM THE IRRIGATION PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2446224 OCTARAY MAPPING CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31740371L 10846835021127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown FARAPULSE SYSTEM.