BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER

    MDR report key: 8511725 · Received April 12, 2019

    Report

    Report Number
    2029046-2019-02979
    Event Type
    Injury
    Date Received
    April 12, 2019
    Date of Event
    March 19, 2019
    Report Date
    March 19, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING AN INTERNAL REVIEW ON APRIL 23, 2019, IT WAS NOTED THAT ¿ MANUFACTURER ADDRESS STREET LINE 1¿ ON THE 3500A INITIAL REPORT NEEDED CORRECTION. IT WAS INITIALLY SUBMITTED AS ¿31 TECHNOLOGY DRIVE¿. THE CORRECT ADDRESS IS ¿33 TECHNOLOGY DRIVE¿. THEREFORE, ¿MANUFACTURER ADDRESS STREET LINE 1¿ HAS BEEN RE-POPULATED. MANUFACTURER'S REF # (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE FOR SUPRAVENTRICULAR TACHYCARDIA WITH AN EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND SUFFERED HEART BLOCK REQUIRING PACEMAKER IMPLANTATION. THE INVESTIGATIONAL ANALYSIS COMPLETED ON 5/13/2019. THE DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND IN GOOD CONDITIONS. THE MAGNETIC SENSOR WAS TESTED ON CARTO AND THE CATHETER WAS PROPERLY VISUALIZED, WITH NO ERRORS WERE OBSERVED. ELECTRICAL TESTING 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. DEFLECTION TESTING WAS PERFORMED AND IT WAS FOUND WITHIN SPECIFICATIONS. THE CATHETER WAS DEFLECTING CORRECTLY. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTIONS WERE IDENTIFIED.  THE CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. THE INSTRUCTIONS FOR USE STATE THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. MANUFACTURE REF NO: (B)(4).

    Additional Manufacturer Narrative · 1

    THE BIOSENSE WEBSTER INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 4/2/2019. INITIAL VISUAL INSPECTION REVEALED NO PHYSICAL DAMAGE. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. ON 4/3/2019, A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE AND NO INTERNAL ACTIONS RELATED TO THIS COMPLAINT WERE FOUND DURING THE REVIEW. CONCOMITANT PRODUCT: C3 EZ STEER CS WITH AUTO ID CATHETER (MODEL# D-1263-07-S, LOT# 30148983M). MANUFACTURE REFERENCE NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE FOR SUPRAVENTRICULAR TACHYCARDIA WITH AN EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND SUFFERED HEART BLOCK REQUIRING PACEMAKER IMPLANTATION. WHILE ABLATING NEAR THE SLOW PATHWAY, THE PATIENT WENT INTO 2:1 ATRIOVENTRICULAR BLOCK. A TEMPORARY PACEMAKER WAS PLACED, AND THE PATIENT REMAINED AN OVERNIGHT TO CONSIDER WHETHER A PERMANENT PACEMAKER IS NEEDED. THERE¿S NO INFORMATION REGARDING PATIENT¿S OUTCOME OR THE PHYSICIAN¿S OPINION. IT WAS ALSO REPORTED DURING THE PROCEDURE, THAT WAS NOISE WAS OBSERVED ON CORONARY SINUS CATHETER SIGNALS BEING DISPLAYED ON CARTO 3 AND RECORDING SYSTEMS. THE CABLE WAS REPLACED, AND THE ISSUE REMAINED. CATHETER REPLACEMENT RESOLVED THE ISSUE AND THE PROCEDURE CONTINUED. THE NOISE ISSUE HAS BEEN ASSESSED AS NOT MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302101 EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION LPB BIOSENSE WEBSTER INC 30055890M 10846835002997

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R