BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY

    MDR report key: 22021713 · Received May 14, 2025

    Report

    Report Number
    2029046-2025-01540
    Event Type
    Malfunction
    Date Received
    May 14, 2025
    Date of Event
    April 21, 2025
    Report Date
    June 13, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835025828
    PMA / PMN Number
    K230253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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 22-MAY-2025, THE PRODUCT INVESTIGATION WAS COMPLETED. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED 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 AN IDIOPATHIC VENTRICULAR TACHYCARDIA - ASC (ACUTE CORONARY SYNDROME) ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND THE MEDICAL TEAM NOTED THAT THE IRRIGATION ON THE DEVICE WAS NOT WORKING CORRECTLY. THE IRRIGATION ISSUE WAS NOTED ONLY AFTER THE DEVICE HAD BEEN USED INSIDE OF THE PATIENT. AFTER PULLING THE CATHETER OUT OF THE BODY, THE IRRIGATION BECAME DISCONNECTED (THE DEVICE HAD ITS OWN IRRIGATION LINE). BLOOD COAGULUM WAS ALSO NOTICED ON THE DEVICE. NO ERROR MESSAGES APPEARED ON THE CATHETER. THE CATHETER WAS REPLACED, AND THE PROBLEM WAS RESOLVED. THE CASE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1230818 OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 10846835025828

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNK_NGEN RF GENERATOR