BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTARAY MICRO

    MDR report key: 22824516 · Received August 17, 2025

    Report

    Report Number
    2029046-2025-02730
    Event Type
    Malfunction
    Date Received
    August 17, 2025
    Date of Event
    July 28, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835021141
    PMA / PMN Number
    K193237
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE INVESTIGATION DETAILS: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER 31577021L 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 REF. # (B)(4).

    Description of Event or Problem · 0

    DURING THE POST-MAP AFTER PULSED FIELD ABLATION (PFA), THE PULSESELECT AND THE SPINES OF OCTARAY MICRO BECAME TANGLED. SINCE THE TANGLING DID NOT RESOLVE, THE PULSESELECT WAS PULLED AND THE OCTARAY¿S SPINE WAS PULLED INTO THE PS SHEATH TO DETACH THE OCTARAY¿S SPINE. THE OCTARAY¿S SPINE WAS DETACHED WHILE IN THE CARDIAC CAVITY. THEN BOTH CATHETERS WERE REMOVED. THE DETACHED SPINE WAS ATTACHED TO THE PS, SO IT WOULD NOT BE REMAINED INSIDE THE CARDIAC CAVITY. THE DETACHMENT WAS DESCRIBED AS A TOTAL DETACHMENT; SPINE WAS SEPARATED. THERE WAS NO RESISTANCE WAS FELT DURING INSERTION. THERE WAS RESISTANCE DURING REMOVAL BECAUSE IT GOT TANGLED WITH PULSESELECT. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2457175 OCTARAY MICRO CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31577021L 10846835021141

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male PULSESELECT| SL0 8.5F SHEATH