BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTARAY MAPPING CATHETER

    MDR report key: 22661958 · Received July 30, 2025

    Report

    Report Number
    2029046-2025-02477
    Event Type
    Injury
    Date Received
    July 30, 2025
    Date of Event
    July 2, 2025
    Report Date
    July 30, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835021110
    PMA / PMN Number
    K193237
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    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 LOT NUMBER 31595284L 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. 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

    IT WAS REPORTED THAT DURING ISCHEMIC VENTRICULAR TACHYCARDIA CARDIAC ABLATION WITH AN OCTARAY CATHETER, THE PATIENT EXPERIENCED PERICARDIAL EFFUSION TREATED WITH CARDIAC ASPIRATION. DURING THE ACCESS PROCESS OF THE PROCEDURE WHILE POSITIONING THE CS (CORONARY SINUS) CATHETER AND THEN DOING THE TRANSSEPTAL, THE PATIENT¿S BP (BLOOD PRESSURE) DROPPED. AN ULTRASOUND WAS DONE, AND IT WAS CONFIRMED THE PATIENT HAD A PERICARDIAL EFFUSION TREATED WITH PERICARDIAL ASPIRATION. THE PATIENT HEMODYNAMICS IMPROVED. THE DOCTOR SUSPECTED THE WIRE USED TO CANNULATE THE CS PERFORATED THE POSTERIOR WALL. NONE OF THE J&J PRODUCTS USED IN THE PROCEDURE WAS SUSPECTED TO BE THE CAUSE. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS TRANSFERRED TO CARDIAC ICU AND HAD ALREADY BEEN IN THE ICU BEFORE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56514 OCTARAY MAPPING CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31595284L 10846835021110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L CARTO 3 SYSTEM| CARTO3 EXTERNAL REFPATCH 6PACK| THMCL SMRTTCH,BI,NAV,TC,D-F,C3