BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY

    MDR report key: 23970069 · Received January 5, 2026

    Report

    Report Number
    2029046-2026-00014
    Event Type
    Malfunction
    Date Received
    January 5, 2026
    Report Date
    February 9, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835025828
    PMA / PMN Number
    K230253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 A CARDIAC ABLATION PROCEDURE WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY. OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY IRRIGATION ISSUE. IMPOSSIBLE TO FLUSH. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J) FOR EVALUATION ON 14-JAN-2026. VISUAL INSPECTION AND IRRIGATION TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING J&J PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. AN IRRIGATION TEST WAS PERFORMED, AND THE CATHETER FAILED THE TEST, THE FLOW IN THE IRRIGATION HOLE WAS VERY POOR. AFTERWARDS, AN ALUMINUM WIRE WAS INTRODUCED IN THE LUER HUB, AND THE WIRE GOT STUCK AT THE TIP AREA. FINALLY, THE SHAFT WAS DISSECTED, AND THE IRRIGATION TUBE WAS INSPECTED, AND IT WAS FOUND THAT THE IRRIGATION TUBE WAS FOLDED AT THE TIP SECTION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE IRRIGATION ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE POTENTIAL CAUSE OF THE FOLDED IRRIGATION TUBING CANNOT BE DETERMINED. THE INSTRUCTION FOR USE (IFU) CONTAIN THE FOLLOWING WARNING AND PRECAUTIONS: FLUSH THE CATHETER WITH HEPARINIZED SALINE PRIOR TO INSERTION INTO THE BODY. ALWAYS FOLLOW STANDARD PRACTICES OF USING A CONTINUOUS DRIP OF ANTICOAGULANT FLUID UNDER PRESSURE THROUGH THE PROXIMAL LUER CONNECTOR WHEN THE DEVICE IS IN THE BODY. 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 REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND IRRIGATION ISSUE (DEVICE USED IN THE PATIENT) WAS OBSERVED. OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY IRRIGATION ISSUE. IMPOSSIBLE TO FLUSH. NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 09 DECEMBER 2025. THE DEVICE WAS USED IN THE PATIENT. PRESSURIZED INFUSION BAGS, SAME USED WITH ANY OTHER CATHETERS (E.G. PENTARAY, OCTARAY, ETC.). NO ERROR, DISCOVERED BY THE PHYSICIAN WHEN TAKING OUT THE CATHETER. THEY TRIED TO FLUSH BUT WAS UNSUCCESSFUL. NO ISSUES WITH FLOW RATE CHANGE AT THE START OF THE ABLATION. THE IRRIGATION ISSUE WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE ON 09-DEC-2025 THAT THE DEVICE WAS USED IN THE PATIENT AND HAVE REASSESSED THE EVENT AS REPORTABLE. THE AWARENESS DATE FOR THIS RECORD IS 09-DEC-2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31297 OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 31482266M 10846835025828

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown