BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTARAY MAPPING CATHETER

    MDR report key: 24570382 · Received March 11, 2026

    Report

    Report Number
    2029046-2026-00803
    Event Type
    Injury
    Date Received
    March 11, 2026
    Date of Event
    February 17, 2026
    Report Date
    March 11, 2026
    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 31820626L AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE 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 A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH AN OCTARAY MAPPING CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS AND SURGICAL INTERVENTION. DURING AN ATRIAL FIBRILLATION CASE A PERICARDIAL EFFUSION WAS DIAGNOSED "AND CONFIRMED" VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE PATIENT'S BLOOD PRESSURE DROPPED. A PERICARDIOCENTESIS WAS PERFORMED BY THE PHYSICIAN. THE PATIENT WAS STABLE AT THE TIME OF THE CALL AND WAS TRANSFERRED TO THE OPERATING ROOM TO "REPAIR THE LEAK". THE BOSTON FARAPULSE PFA ABLATION GENERATOR WAS THE ONLY GENERATOR USED DURING THE CASE. THE FOLLOWING J&J MEDTECH ELECTROPHYSIOLOGY PRODUCTS WERE USED DURING THE CASE: CARTO 3 REFERENCE PATCHES - LOT 027860, REFERENCE NUMBER: (B)(4) OCTARAY MAPPING CATHETER- LOT NUMBER: 31820626L, REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629937 OCTARAY MAPPING CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31820626L 10846835021127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L BOSTON FARAPULSE PFA ABLATION GENERATOR| CARTO 3 REFERENCE PATCHES| CARTO 3 SYSTEM| CS EZ STEER CATHETER| SOUNDSTAR CATHETER