BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER

    MDR report key: 8796510 · Received July 16, 2019

    Report

    Report Number
    2029046-2019-03424
    Event Type
    Injury
    Date Received
    July 16, 2019
    Date of Event
    June 19, 2019
    Report Date
    June 20, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835002997
    PMA / PMN Number
    P990025/S12
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. ON 6/27/2019, A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30182763M NUMBER, AND NO INTERNAL ACTIONS WERE FOUND DURING THE REVIEW. NO CODE AVAILABLE WAS USED TO REPRESENT SURGICAL INTERVENTION. MANUFACTURE REFERENCE NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT IN THEIR MID-SIXTIES UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH AN EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND SUFFERED ATRIOVENTRICULAR (AV) HEART BLOCK REQUIRING SURGICAL INTERVENTION. DURING THE PROCEDURE, THE PATIENT WENT INTO AV HEART BLOCK. VENTRICULAR PACING FOLLOWED BY A PERMANENT PACEMAKER IMPLANTATION WAS REQUIRED. THE PATIENT WAS REPORTED IN STABLE CONDITION AND WAS TRANSFERRED TO THE CORONARY CARE UNIT (CCU). THE AV NODE DID NOT RECOVER BUT THE PACEMAKER RESTORED CARDIAC FUNCTIONALITY. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE AND PATIENT CONDITION RELATED. NO BIOSENSE WEBSTER INC. PRODUCT MALFUNCTIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588910 EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION LPB BIOSENSE WEBSTER INC 30182763M 10846835002997

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S