BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTARAY MAPPING CATHETER

    MDR report key: 22020951 · Received May 14, 2025

    Report

    Report Number
    2029046-2025-01539
    Event Type
    Injury
    Date Received
    May 14, 2025
    Date of Event
    April 21, 2025
    Report Date
    May 14, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835021127
    PMA / PMN Number
    K193237
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 NUMBER LOT 31532278L 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

    THE REPORT INDICATED THAT DURING LEFT SIDED ATRIAL FLUTTER ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER, THE PATIENT EXPERIENCED TACHYCARDIA, DROPPED OXYGEN LEVEL, AND A PERICARDIAL EFFUSION WAS NOTED TREATED WITH PERICARDIOCENTESIS. THE INFORMATION INDICATED THAT DURING A LEFT-SIDED ATRIAL FLUTTER CASE, A PERICARDIAL EFFUSION WAS NOTICED IN THE PATIENT. TOWARDS THE END OF THE PROCEDURE, IT WAS NOTICED THAT THE PATIENT'S OXYGEN LEVELS HAD DROPPED ON THE ANESTHESIA MONITOR. THE SOUNDSTAR® CATHETER WAS PULLED BACK TO THE RIGHT VENTRICLE, AND A PERICARDIAL EFFUSION WAS THEN DISCOVERED ON ICE (INTRACARDIAC ECHOCARDIOGRAPHY). THE PERICARDIAL EFFUSION WAS CONFIRMED VIA ECHO (ECHOCARDIOGRAPHY). THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS, AND OVER 700CC OF FLUID WAS REMOVED, WITH SOME OF IT BEING RECYCLED BACK TO THE PATIENT. THE EXACT AMOUNT OF FLUID THAT WAS REMOVED COULD NOT BE CONFIRMED, OR THE AMOUNT RECYCLED BACK TO THE PATIENT. THE PATIENT IS IN STABLE CONDITION. A FARAPULSE¿ SYSTEM WAS IN USE, AND NO BWI ABLATION CATHETER WAS IN USE. A SOUNDSTAR® CATHETER (STERILMED REPROCESSED), AND WEBSTER® CS UNI-DIRECTIONAL CATHETER WAS USED DURING THE PROCEDURE. NONE OF THE BWI CATHETERS ARE AVAILABLE FOR RETURN. INTERVENTION PROVIDED WAS PULSE FIELD ABLATION, FARAPULSE BOSTON SCIENTIFIC, AND THE OUTCOME OF THE ADVERSE EVENT WAS FULLY RECOVERED (NO RESIDUAL EFFECTS). THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF ICU ADMISSION, AND THE PATIENT DID NOT REQUIRED . PRIOR TO NOTING THE PERICARDIAL EFFUSION, PULSE FIELD ABLATION (PFA) WAS PERFORMED, AND THE EVENT OCCUR POST ABLATION/MAPPING. NO EVIDENCE OF STEAM POP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1909860 OCTARAY MAPPING CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31532278L 10846835021127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R FARAPULSE¿ SYSTEM.| SOUNDSTAR® CATHETER.| WEBSTER® CS UNI-DIRECTIONAL CATHETER.