BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY

    MDR report key: 21829753 · Received April 11, 2025

    Report

    Report Number
    2029046-2025-01122
    Event Type
    Malfunction
    Date Received
    April 11, 2025
    Date of Event
    March 18, 2025
    Report Date
    May 12, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    PMA / PMN Number
    K230253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    ON (B)(6) 2025, THE PRODUCT INVESTIGATION WAS COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND AN IRRIGATION OCCLUSION OCCURRED. THE ISSUE WAS NOTED DURING MAPPING. NO ERROR CODE WAS NOTED FROM THE INFUSION PUMP. HOWEVER, SINCE AN ALERT APPEARED CONTINUOUSLY DESPITE IRRIGATION WAS BEING CARRIED OUT, IT WAS DETERMINED AS AN ISSUE THAT THE VOLUME OF IRRIGATION GOT DECREASED. THE OPTRELL WAS REPLACED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J) FOR EVALUATION. 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 THE IRRIGATION TUBE FOUND FOLDED AT THE TIP SECTION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31388679M AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. 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. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH J&J'S QUALITY SYSTEM. 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 A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND AN IRRIGATION OCCLUSION OCCURRED. THE ISSUE WAS NOTED DURING MAPPING. NO ERROR CODE WAS NOTED FROM THE INFUSION PUMP. HOWEVER, SINCE AN ALERT APPEARED CONTINUOUSLY DESPITE IRRIGATION WAS BEING CARRIED OUT, IT WAS DETERMINED AS AN ISSUE THAT THE VOLUME OF IRRIGATION GOT DECREASED. THE OPTRELL WAS REPLACED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2348501 OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 31388679M

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown