BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY

    MDR report key: 22028632 · Received May 15, 2025

    Report

    Report Number
    2029046-2025-01564
    Event Type
    Injury
    Date Received
    May 15, 2025
    Date of Event
    April 22, 2025
    Report Date
    May 15, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    PMA / PMN Number
    K230253
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION WHICH REQUIRED PERICARDIOCENTESIS AND BLOOD TRANSFUSION. THE REPORT INDICATED THAT THERE WAS NOISE ON LEAD V1. THE DISPOSABLE EKG PATCHES WERE REPLACED AND THE LEADS RE-SEATED AND THE ISSUE DID NOT RESOLVE. THE 12-LEAD CABLE WAS REPLACED AND THE ISSUE RESOLVED. THEN AFTER GOING TRANSSEPTAL, A SMALL EFFUSION WAS SEEN WITH ULTRASOUND (US). A VIZIGO SHEATH, DECANAV CATHETER, AND AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY WERE PLACED. MAPPING WAS STARTED WITH THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND THEN STARTED TO SEE THE EFFUSION GROW WITH US AND THE PATIENT¿S BLOOD PRESSURE DROPPED TO 60/40. A PERICARDIOCENTESIS WAS PERFORMED AND APPROXIMATELY 2 LITERS OF FLUID WAS DRAINED. THEY BEGAN BLOOD TRANSFUSIONS. THE PATIENT STABILIZED WITHOUT SURGERY AND WAS BOUGHT FOR OBSERVATION. NO ABLATIONS WERE PERFORMED. ADDITIONAL INFORMATION WAS RECEIVED. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS TRANSSEPTAL WITH ABBOTT BRK NEEDLE, AND THE PATIENT REQUIRED EXTENDED HOSPITALIZATION AND WAS IN INTENSIVE CARE UNIT (ICU). IRRIGATED OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND VIZIGO SHEATH WERE USED DURING THE PROCEDURE AND IRRIGATION FLOW SETTINGS WERE STANDARD. THE NOISE ISSUE / CABLE PROBLEM WERE ASSESSED AS NON MDR REPORTABLE UNDER THE CARTO 3 SYSTEM. THE ADVERSE EVENT WAS ASSESSED AS MDR REPORTABLE UNDER THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2102932 OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Life Threatening| R| H 7FR DECAN,11P,F,2.4MMLE,282MM,| 8.5F SHEATH WITH CURVE VIZ MDC| ABBOTT BRK NEEDLE| CARTO 3 SYSTEM| NGEN PUMP, US CONFIGURATION| NGEN RF GENERATOR, US| SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER