BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY

    MDR report key: 23938947 · Received January 1, 2026

    Report

    Report Number
    2029046-2026-00001
    Event Type
    Injury
    Date Received
    January 1, 2026
    Date of Event
    December 5, 2025
    Report Date
    February 12, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835025828
    PMA / PMN Number
    K230253
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31636890M AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS 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 REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 15-JAN-2026 WHICH INDICATED THAT THE VIZIGO SHEATH WAS DISCARDED. 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 NON-ISCHEMIC VENTRICULAR TACHYCARDIA (NON-ISVT) ABLATION PROCEDURE WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND VIZIGO. THE OPTRELL CATHETER COULD NOT BE REMOVED FROM THE PATIENT¿S GROIN THROUGH THE VIZIGO SHEATH AND SURGICAL INTERVENTION WAS REQUIRED FOR REMOVAL. IT WAS REPORTED THAT THE RIGHT VENTRICLE (RV) CATHETER WENT THROUGH OPTRELL CATHETER AND WHEN OPTRELL WAS REMOVED, THE VIZIGO BENT INSIDE THE PATIENT AND COULD NOT BE REMOVED FROM THE PATIENT¿S GROIN. THE INTRODUCER WAS REMOVED SURGICALLY FROM THE GROIN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT FOR THIRTY (30) MINUTES. ADDITIONAL INFORMATION INDICATED THAT THERE WAS RESISTANCE BETWEEN THE VASCULATURE; HOWEVER, THERE WAS NO ALTERATION ON SHAFT SURFACE. THE RESISTANCE RESULTED IN DAMAGE TO THE SHEATH. THERE WAS NO RESISTANCE TO SHEATH WHEN THEY WERE TRYING TO PUT THE CATHETER/DILATOR INTO THE SHEATH. THE CATHETER OR WIRE COULD NOT BE PUT THROUGH THE SHEATH. THE RESISTANCE RESULTED IN DAMAGE TO THE DILATOR THAT BENT LIKE A U-TURN. THE DILATOR/CATHETER/NEEDLE COULD NOT BE MOVED WITHIN THE SHEATH; HOWEVER, NOTHING WAS STUCK INSIDE THE SHEATH. THE PATIENT WAS IN THE ROOM AT THE TIME OF THE DELAY, WHICH WAS FOR THREE (3) HOURS, SINCE THE PATIENT NEEDED SURGERY. WHEN THE RV QUAD WENT THROUGH THE CATHETER NOTHING HAPPENED. THE OPTRELL AND RV-CATHETER WERE BOTH IN THE RIGHT VENTRICLE. THE CATHETERS TANGLED EACH OTHER WHEN MAPPING WITH OPTRELL CATHETER. IT WAS NOT NOTICED THAT CATHETERS WERE TANGLED UNTIL OPTRELL WAS REMOVED. NO DAMAGE WAS REPORTED TO THE OPTRELL CATHETER. THE VIZIGO SHEATH WAS BENT WHEN ATTEMPTING TO REMOVE THE OPTRELL CATHETER AND SURGERY WAS REQUIRED. THE PATIENT DID NOT REQUIRE PROLONGED HOSPITALIZATION. THE PATIENT FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246 OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31636890M 10846835025828

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention RV CATHETER| UNK_CARTO VIZIGO SHEATH