BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTARAY, GALAXY, 48P, 2-5-2-5-2, F-CURVE

    MDR report key: 18024835 · Received October 27, 2023

    Report

    Report Number
    2029046-2023-02465
    Event Type
    Malfunction
    Date Received
    October 27, 2023
    Date of Event
    October 3, 2023
    Report Date
    October 27, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835021158
    PMA / PMN Number
    K193237
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. HOWEVER, A PICTURE WAS RECEIVED FOR EVALUATION FOLLOWING BIOSENSE WEBSTER'S PROCEDURES. DEVICE INVESTIGATION DETAILS: ACCORDING TO PICTURES PROVIDED BY THE CUSTOMER, A THROMBUS WAS OBSERVED ATTACHED TO THE TIP ON A ELECTRODE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR FINISHED DEVICE NUMBER 31077671L, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON THE PICTURE RECEIVED. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PAROXYSMAL ABLATION PROCEDURE WITH A OCTARAY, GALAXY, 48P, 2-5-2-5-2, F-CURVE. AFTER THE END OF THE PROCEDURE, OCTARAY WAS REMOVED FROM THE PATIENT AND A LARGE THROMBUS WAS ATTACHED TO THE CATHETER. THE ACTIVATED CLOTTING TIME (ACT) WAS IN THERAPEUTIC LEVEL THE WHOLE TIME OCTARAY WAS PRESENT IN THE LEFT ATRIUM (LA). THE OCTARAY AND THE SHEATH WAS FLUSHED WITH HEPARINISED SALINE. A PRESSURE BAG WAS ATTACHED TO THE OCTARAY FLUSH. THE FLUSH WAS NOT OBSTRUCTED. NO ABLATION WAS PERFORMED ON OR CLOSE TO THE OCTARAY. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1951222 OCTARAY, GALAXY, 48P, 2-5-2-5-2, F-CURVE CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31077671L 10846835021158

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown