BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER

    MDR report key: 8608001 · Received May 14, 2019

    Report

    Report Number
    2029046-2019-03138
    Event Type
    Injury
    Date Received
    May 14, 2019
    Date of Event
    April 23, 2019
    Report Date
    April 23, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 5/21/2019, THE COMPLAINT PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC.¿S (BWI) PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. INITIAL VISUAL ANALYSIS FOUND NO VISUAL DAMAGE OR ANOMALIES OBSERVED. THE PRODUCT ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A 49-YEAR-OLD FEMALE PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH AN EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND SUFFERED COMPLETE HEART BLOCK REQUIRING SURGICAL INTERVENTION. A PACEMAKER WAS IMPLANTED. EXTENDED HOSPITALIZATION WAS REQUIRED TO RECOVER FROM PACEMAKER IMPLANTATION. THE ADVERSE EVENT WAS ASSESSED AS ¿DISABILITY OR PERMANENT DAMAGE¿ SINCE THE PATIENT¿S INTRINSIC CONDUCTION SYSTEM, WAS DAMAGED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE RELATED. NO BWI PRODUCT MALFUNCTIONS WERE REPORTED. DEVICE EVALUATION DETAILS: THE DEVICE EVALUATION HAS BEEN COMPLETED. THE DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND IN GOOD CONDITIONS. A MAGNETIC SENSOR WAS TESTED ON CARTO AND THE CATHETER WAS PROPERLY VISUALIZED AND NO ERRORS WERE OBSERVED. AN ELECTRICAL TEST WAS PERFORMED ON THE CATHETER AND IT WAS FOUND WITHIN SPECIFICATIONS. NO ELECTRICAL MALFUNCTION WAS OBSERVED. ADDITIONALLY, THE CATHETER WAS TESTED ON THE GENERATOR AND THE TEMPERATURE AND IMPEDANCE VALUES WERE OBSERVED WITHIN SPECIFICATIONS. AFTER THAT, THE DEFLECTION TEST WAS PERFORMED AND IT WAS FOUND WITHIN SPECIFICATIONS, THE CATHETER WAS DEFLECTING CORRECTLY. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. THE CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE RELATED. NO BWI PRODUCT MALFUNCTIONS WERE REPORTED. MANUFACTURER¿S REF # (B)(4).

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30182773M NUMBER, AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH AN EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND SUFFERED COMPLETE HEART BLOCK REQUIRING SURGICAL INTERVENTION. DURING THE PROCEDURE, THE PATIENT DEVELOPED COMPLETE HEART BLOCK. A PACEMAKER WAS IMPLANTED. EXTENDED HOSPITALIZATION WAS REQUIRED TO RECOVER FROM PACEMAKER IMPLANTATION. THE ADVERSE EVENT WAS ASSESSED AS ¿DISABILITY OR PERMANENT DAMAGE¿ SINCE THE PATIENT¿S INTRINSIC CONDUCTION SYSTEM, WAS DAMAGED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE RELATED. NO BWI PRODUCT MALFUNCTIONS WERE REPORTED. THE PATIENT¿S DIAGNOSIS PRE-PROCEDURE WAS SUPRAVENTRICULAR TACHYCARDIA (SVT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401856 EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION LPB BIOSENSE WEBSTER INC. 30182773M 10846835002997

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R| S