BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAPPING CATHETER WITH TRUEREF TECHNOLOGY

    MDR report key: 23932518 · Received December 31, 2025

    Report

    Report Number
    2029046-2025-04367
    Event Type
    Injury
    Date Received
    December 31, 2025
    Date of Event
    December 8, 2025
    Report Date
    December 31, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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. 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. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. 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

    DURING ISVT (ISCHEMIC SUPRAVENTRICULAR TACHYCARDIA) ABLATION PROCEDURE WITH OPTRELL MAPPING CATHETER, WHILE MAPPING, THE PATIENT EXPERIENCED A STROKE THAT THEY FULLY RECOVERED FROM.THE PHYSICIAN WAS MAPPING THE LEFT VENTRICLE VIA TRANSEPTAL ACCESS WITH THE OPTRELL CATHETER AND VIZIGO SHEATH. THE PATIENT WAS UNDER CONSCIOUS SEDATION. MAPPING BEGAN IN SINUS RHYTHM, AND A VT (VENTRICULAR TACHYCARDIA) WAS INDUCED BY CATHETER MANIPULATION, SO VT WAS ALSO MAPPED. WHILST MAPPING AN ANTERIOR ANEURYSM WAS IDENTIFIED BY THE CARTO 3D MAPPING SYSTEM. THE SURGEON NOTICED THE PATIENT BECAME CONFUSED AND WASN¿T COHERENT. ALL CATHETERS WERE REMOVED IMMEDIATELY FROM THE LEFT VENTRICLE. THE PATIENT WAS STRUGGLING TO MOVE HIS RIGHT ARM AND VISUALLY THE RIGHT SIDE OF THE FACE LOOKED DROOPED. THE PATIENT WAS THEN TAKEN FOR A CT (COMPUTED TOMOGRAPHY) SCAN AND LATER WAS CONFIRMED WAS FULLY RECOVERED. POST CASE, THE SURGEON BELIEVES THAT A THROMBUS FROM THE ANEURYSM BROKE FREE DUE TO CATHETER MANIPULATION WITHIN THE LEFT VENTRICLE, BUT IT WAS NOT DUE TO THE OPTRELL CATHETER. IT WAS INDICATED THAT THE PROCEDURE START WAS 9:30AM AND PROCEDURE END WAS 11:50 AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2570626 MAPPING CATHETER WITH TRUEREF TECHNOLOGY CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L CARTO 3 SYSTEM| UNK_CARTO VIZIGO SHEATH| UNK_GENERATOR