BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY

    MDR report key: 23770958 · Received December 10, 2025

    Report

    Report Number
    2029046-2025-04087
    Event Type
    Injury
    Date Received
    December 10, 2025
    Date of Event
    November 17, 2025
    Report Date
    February 4, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835025828
    PMA / PMN Number
    K230253
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 12-JAN-2026, THE PRODUCT INVESTIGATION WAS COMPLETED AS THE COMPLAINT DEVICE WAS NOT RETURNED. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    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).

    Description of Event or Problem · 0

    AFTER A SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY, THE PATIENT EXPERIENCED BLOOD PRESSURE DROP AND PERICARDIAL EFFUSION WHILE PULLING THE CATHETER TREATED INITIALLY WITH PROTAMINE FOLLOWED BY PERICARDIOCENTESIS. THE PATIENT WAS STABLE. IT WAS REPORTED AFTER AN SVT CASE, A PERICARDIAL EFFUSION WAS NOTICED. AT THE END OF THE PROCEDURE WHILE PULLING OUT THE CATHETERS, THE MEDICAL TEAM GAVE PROTAMINE THEN THEY NOTICED A DROP IN BLOOD PRESSURE ON THE PATIENT. THE PERICARDIAL EFFUSION WAS CONFIRMED BY TRANSTHORACIC ECHO. THE MEDICAL INTERVENTION PROVIDED WAS PERICARDIOCENTESIS. THEY FIRST GAVE A LITTLE MORE PROTAMINE BUT THEN ENDED UP ¿TAPPING AND DRAINING¿ THE PATIENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THEY DIDN¿T COMPLETE ANY ABLATION DURING THE PROCEDURE. AN OPTRELL CATHETER WAS USED FOR MAPPING. THEY ALSO USED A CARTO 3 SYSTEM, DECA NAV CATHETER AND A QUAD CATHETER DURING THE PROCEDURE. NO GENERATOR WAS USED DURING THE PROCEDURE. THE PHYSICIAN DID NOT THINK THE OPTRELL CATHETER CAUSED THE ISSUE AND BELIEVED IT WAS THE RIGHT ATRIAL OR RIGHT VENTRICULAR CATHETER. NO ADDITIONAL DETAILS OR INFORMATION WAS PROVIDED. NO GENERATORS WERE USED FOR ABLATION DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450214 OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 31599285M 10846835025828

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R CARTO 3 SYSTEM.| DECA NAV CATHETER.| QUAD CATHETER.