BEUDAMED
    FDA Adverse Event Death Summary report: N

    OCTARAY MAPPING CATHETER

    MDR report key: 22613179 · Received July 25, 2025

    Report

    Report Number
    2029046-2025-02444
    Event Type
    Death
    Date Received
    July 25, 2025
    Date of Event
    July 1, 2025
    Report Date
    July 25, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835021134
    PMA / PMN Number
    K193237
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 LOT NUMBER 31642001L 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CARDIAC ABLATION PROCEDURE WHICH INCLUDED THE USE OF AN OCTARAY MAPPING CATHETER, THE PATIENT EXPERIENCED TAMPONADE THAT REQUIRED DRAINAGE. THE PATIENT DIED. CARDIAC TAMPONADE OCCURRED DURING THE PROCEDURE. THE OCTARAY WAS THE ONLY DEVICE USED DURING THE CASE; HOWEVER, THE PHYSICIAN THOUGHT THAT IT WAS DUE TO THE TRANSSEPTAL. "QUICK MINUTES" AFTER THE MAPPING STARTED, THE BLOOD PRESSURE HAD FALLEN AND THEY DID AN ECHOCARDIOGRAPHY AND THEY SAW A MAJOR TAMPONADE. HE DIRECTLY STOPPED THE MAPPING AND TREATED THE TAMPONADE. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS THE PUNCTURE OF THE TRANSSEPTAL AND THAT THERE WAS NO IMPLICATION WITH BIOSENSE WEBSTER (BWI) PRODUCTS. THE PUNCTURE WAS DONE WITH THE ETO AND BRK 71CM. HOWEVER, THE EVENT WAS DISCOVERED AT THE START OF MAPPING. NO ABLATION CATHETER WAS USED. THERE WAS NO ERROR MESSAGE OBSERVED ON BWI EQUIPMENT DURING THE PROCEDURE. INTERVENTION WAS PROVIDED WHICH INCLUDED THE PHYSICIAN DRAINED THE PATIENT; HOWEVER, THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2174265 OCTARAY MAPPING CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31642001L 10846835021134

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| D| L ETO AND BRK TRANSSEPTAL NEEDLE 71CM