BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER

    MDR report key: 8258003 · Received January 17, 2019

    Report

    Report Number
    2029046-2019-02584
    Event Type
    Injury
    Date Received
    January 17, 2019
    Date of Event
    December 28, 2018
    Report Date
    December 28, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835003031
    PMA / PMN Number
    P990025/S12
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA (AVRNT) WITH AN EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND SUFFERED HEART BLOCK AV REQUIRING NO MEDICAL/SURGICAL INTERVENTION. DURING THE PROCEDURE, HEART BLOCK AV WAS NOTICED. THE ATRIAL BEATS WERE NOT ONE TO ONE WITH THE VENTRICULAR BEATS. THE VENTRICLE WAS BEING PACED DUE TO THE PATIENT HAVING A DEVICE. THE HEART BLOCK DID NOT NEED ANY TYPE OF MEDICAL INTERVENTION. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. IT IS UNKNOWN IF EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT¿S OUTCOME IS UNCHANGED. 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 AND NO ERRORS WERE OBSERVED. THEN, 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. THEN, DEFLECTION TEST WAS PERFORMED, AND IT WAS FOUND WITHIN SPECIFICATIONS, THE CATHETER WAS DEFLECTING CORRECTLY. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. THE IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE. MANUFACTURER'S REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 0

    DURING AN INTERNAL REVIEW ON 3/9/2019, IT WAS DETERMINED THAT SECTION G4 DATE RECEIVED BY MANUFACTURER WAS NOT POPULATED CORRECTLY WITH THE DATE OF 12/28/2018 WHEN THE SUPPLEMENTAL 3500A REPORT WAS SUBMITTED. THEREFORE, A SUPPLEMENTAL 3500A IS BEING SUBMITTED AND THE CORRECT DATE FOR G4 DATE RECEIVED BY MANUFACTURER FOR FOLLOW UP #1 WAS 2/11/2019. THE AWARENESS DATE FOR THIS REPORT (FOLLOW UP #2) IS 3/9/2019. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. 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. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 30130234M HAS BEEN REVIEWED AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. ON JANUARY 11, 2019, THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE PRODUCT AND IT WAS OBSERVED THAT THERE WAS NO PHYSICAL DAMAGE UPON INITIAL VISUAL INSPECTION. MANUFACTURER'S "REERENCE" #: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA ("AVRNT") WITH AN EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND SUFFERED HEART BLOCK AV REQUIRING NO MEDICAL/SURGICAL INTERVENTION. DURING THE PROCEDURE, HEART BLOCK AV WAS NOTICED. THE ATRIAL BEATS WERE NOT ONE TO ONE WITH THE VENTRICULAR BEATS. THE VENTRICLE WAS BEING PACED DUE TO THE PATIENT HAVING A DEVICE. THE HEART BLOCK DID NOT NEED ANY TYPE OF MEDICAL INTERVENTION. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. IT IS UNKNOWN IF EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT¿S OUTCOME IS UNCHANGED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT OCCURRED DUE TO ABLATING ON THE NODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49060 EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION LPB BIOSENSE WEBSTER INC 30130234M 10846835003031

    Patients

    Seq Age Sex Outcome Treatment
    1 Other