BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY

    MDR report key: 24141731 · Received January 21, 2026

    Report

    Report Number
    2029046-2026-00274
    Event Type
    Malfunction
    Date Received
    January 21, 2026
    Date of Event
    December 26, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835025828
    PMA / PMN Number
    K230253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE INVESTIGATION DETAILS: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT: 31712378M AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED 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 REF.#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE BIOSENSE WEBSTER INC REPRESENTATIVE THAT THE INTRODUCER OF THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY HAD A SMALLER FLAIR THAN THE AGILIS¿ 13F SHEATH AND THE INTRODUCER WENT INSIDE THE SHEATH AND GOT STUCK. THIS HAPPENED AT THE END OF THE CASE AND THEY PULLED EVERYTHING OUT WITHOUT ANY PROBLEMS. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189197 OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 31712378M 10846835025828

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown AGILIS¿ 13F SHEATH.| FARAPULSE¿ PFA SYSTEM.| OPTRELL, 36 ELECTRODES, D-F.