BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER

    MDR report key: 11322695 · Received February 12, 2021

    Report

    Report Number
    2029046-2021-00166
    Event Type
    Injury
    Date Received
    February 12, 2021
    Date of Event
    January 14, 2021
    Report Date
    January 14, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835002997
    PMA / PMN Number
    P990025/S12
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 2/19/2021, BIOSENSE WEBSTER INC. RECEIVED ADDITIONAL INFORMATION INDICATING THERE WERE THREE (3) EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER USED DURING THIS PROCEDURE. THE REVERSED IMAGE ISSUE OCCURRED WITH THE VERY FIRST EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER USED AND THAT WAS WELL BEFORE ANY ABLATION. THE SECOND EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER HAD THE 401 ERROR. THE THIRD EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER WAS USED TO MAP AND ABLATE THE PATIENT WHO SUBSEQUENTLY HAD THE COMPLICATION. BASED ON THIS NEW INFORMATION, IT HAS BEEN DETERMINED THE REPORTABLE ADVERSE EVENT WILL BE REPORTABLE ONLY AGAINST THE THIRD CATHETER UNDER METWATCH REPORT # 2029046-2021-00373. THE ADVERSE EVENT IS NO LONGER REPORTABLE AGAINST THIS CATHETER SINCE THE ERROR 401 (UNABLE TO MAP) ISSUE IS NOT AN MDR REPORTABLE MALFUNCTION. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 1

    ON 2/8/2021, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. INITIAL VISUAL ANALYSIS FOUND THE CATHETER IN GOOD, NORMAL CONDITION. 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. SINCE THE EZ STEER" NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETERS USED WERE OF THE SAME PRODUCT CODE AND THE SAME LOT NUMBER THE REPORTABLE PATIENT ADVERSE EVENT WILL BE REPORTED AGAINST BOTH. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO REPORTS: MFR # 2029046-2021-00165 FOR PRODUCT CODE BN7TCDF4L (EZ STEER" NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER). FOR PRODUCT CODE BN7TCDF4L (EZ STEER" NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT WITH HISTORY OF SUPRAVENTRICULAR TACHYCARDIA (SVT), UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH A EZ STEER" NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND SUFFERED ATRIOVENTRICULAR (AV) HEART BLOCK 3RD DEGREE REQUIRING SURGICAL INTERVENTION (PACEMAKER IMPLANTATION) AND STEROIDS ADMINISTRATION. WHILE ABLATING THE SLOW PATHWAY, AN AV 3RD DEGREE HEART BLOCK WAS NOTICED. THE HEART BLOCK WAS CONFIRMED BY THE ELECTROGRAM. INTRAVENOUS (IV) STEROIDS WERE GIVEN TO THE PATIENT. AFTER THE STEROIDS ADMINISTERED, THE PATIENT WAS MONITORED FOR 45 MINUTES. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION BUT IS STILL IN THIRD-DEGREE HEART BLOCK. A TEMPORARY PACEMAKER WAS IMPLANTED. PROLONGED HOSPITALIZATION WAS REQUIRED TO MONITOR THE PATIENT AND TO POSSIBLY IMPLANT A PERMANENT PACEMAKER. IT IS UNKNOWN IF A PERMANENT PACEMAKER WAS LATER IMPLANTED. PATIENT CONDITION UNCHANGED. PHYSICIAN DID NOT GIVE ANY REASON OR CAUSE FOR THE ISSUE. HE MAINTAINED ADEQUATE DISTANCE FROM THE HIS AND USED PRODUCTS WITHIN THE INSTRUCTIONS FOR USE (IFU). CATHETER WAS REPLACED. IT WAS ALSO REPORTED THAT DURING THE PROCEDURE THERE WAS AN ISSUE WITH ONE THE EZ STEER" NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AS IT WAS APPEARING REVERSED ON THE CARTO 3 SYSTEM; THE CATHETER WAS REPLACED WITH ANOTHER ONE FROM THE SAME LOT # AND THE ISSUE WAS RESOLVED. THE CARTO 3 SYSTEM WAS DISPLAYING A 401-"CATHETER SENSOR ERROR." THE CABLE WAS REPLACED WITHOUT RESOLUTION. THE CARTO 3 SYSTEM WAS REBOOTED WITHOUT RESOLUTION. THE EZ STEER" NAV BI-DIRECTIONL ELECTROPHYSIOLOGY CATHETER, THE CATHETER WAS REPLACED. THE REPORTED REVERSED ICON AND SENSOR ERRORS ARE NOT CONSIDERED TO BE MDR REPORTABLE MALFUNCTION SINCE THE ISSUES ARE HIGHLY DETECTABLE ISSUE. THE MOST LIKELY CONSEQUENCE IS AN INTRAPROCEDURAL DELAY. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH IS REMOTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219905 EZ STEER NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION LPB BIOSENSE WEBSTER INC BN7TCDF4L 30429402M 10846835002997

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R 4MM NAVIGATIONAL BI-DIRECT| CARTO 3 SYSTEM