BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTARAY MAPPING CATHETER

    MDR report key: 23844355 · Received December 18, 2025

    Report

    Report Number
    2029046-2025-04221
    Event Type
    Malfunction
    Date Received
    December 18, 2025
    Date of Event
    September 26, 2025
    Report Date
    December 18, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835021233
    PMA / PMN Number
    K193237
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE INVESTIGATION DETAILS. VISUAL ANALYSIS REVEALED ELECTRODES LIFTED AND HAD A PLASTIC ATTACHED IN THE SPLINES. A FOURIER TRANSFORM INFRARED SPECTROSCOPY WAS PERFORMED AND REVEALED THAT THE PLASTIC ATTACHED IN THE SPLINES WAS POLYTETRAFLUOROETHYLENE (PT-FE). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE PT-FE AND LIFTED ELECTRODE OBSERVED COULD BE RELATED TO THE EVENT REPORTED BY THE CUSTOMER, THEREFORE, THE COMPLAINT WAS CONFIRMED. THE PT-FE IN THE SPLINE AND BENT AND LIFTED ELECTRODE COULD BE RELATED TO THE MANIPULATION OF THE DEVICE WITH A SHEATH DURING THE PROCEDURE, HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING RECOMMENDATIONS: THE CATHETER IS RECOMMENDED FOR USE WITH AN 8.5 F GUIDING SHEATH BECAUSE THE DISTAL SPINES MAY BE DAMAGED IF USED WITH A SHEATH THAT IS NOT COMPATIBLE. DO NOT USE THE CATHETER IN CONJUNCTION WITH A TRANSSEPTAL SHEATH FEATURING SIDE HOLES LARGER THAN 1.25 MM IN DIAMETER; DO NOT INTRODUCE THE CATHETER INTO A GUIDING SHEATH WITH THE CATHETER¿S DISTAL SPINES FOLDED BACK TOWARD THE HANDLE. COLLAPSE THE SPINES TOGETHER USING THE INSERTION TUBE PRIOR TO INSERTION; DO NOT PRE-BEND THE CATHETER. EXCESSIVE BENDING OR KINKING OF THE CATHETER SHAFT OR SPINES MAY DAMAGE LEAD WIRES AND CAUSE LOSS OF ELECTRODE FUNCTION; DO NOT USE EXCESSIVE FORCE TO ADVANCE OR WITHDRAW THE CATHETER THROUGH THE GUIDING SHEATH IF RESISTANCE IS ENCOUNTERED. AS PART OF JOHNSON & JOHNSON MEDTECH'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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).

    Description of Event or Problem · 0

    INITIALLY, IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION AFIB ¿ PERSISTENT ABLATION PROCEDURE WITH A VIZIGO AND AFTER FINISHING THE PROCEDURE WITHOUT ANY INCIDENCES OR ABNORMAL EVENTS, ALL CATHETERS AND SHEATHS WERE REMOVED FROM THE PATIENT'S BODY AND IT WAS NOTICED THAT A STRANGE THREAD OF SOME KIND OF PLASTIC MATERIAL WAS WRAPPED AROUND AND HANGING FROM THE BASE OF THE SPLINES OF THE OCTARAY CATHETER. THE PHYSICIAN DID NOT EXPERIENCE ANY DIFFICULTY OR ABNORMALITIES IN THE HANDLING DURING THE CASE. THE CATHETER WAS USED IN THE LEFT ATRIUM (LA) VIA A VIZIGO SHEATH, WHICH UNFORTUNATELY WAS ALREADY DISCARDED AND NOT AVAILABLE FOR RETURN. NO PATIENT CONSEQUENCES HAVE BEEN OBSERVED SO FAR. WITH THE INITIAL INFORMATION AVAILABLE, THIS EVENT WAS ASSESSED AS MDR REPORTABLE AGAINST VIZIGO AND AN INITIAL 3500A REPORT WAS SUBMITTED TO THE FDA ON 29-OCT-2025 UNDER REPORT#: 2029046-2025-03614. HOWEVER, THE OCTARAY DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION AND FOURIER TRANSFORM INFRARED SPECTROSCOPY (FT-IR) OF THE RETURNED DEVICE WERE PERFORMED. VISUAL ANALYSIS REVEALED ELECTRODES LIFTED AND HAD A PLASTIC ATTACHED IN THE SPLINES. THIS FINDING IS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2243877 OCTARAY MAPPING CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31699739L 10846835021233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown VIZIGO SHEATH.