BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER NAV CATHETER

    MDR report key: 22890022 · Received August 25, 2025

    Report

    Report Number
    2029046-2025-02833
    Event Type
    Injury
    Date Received
    August 25, 2025
    Date of Event
    July 31, 2025
    Report Date
    August 25, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    THE DAY AFTER AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) CARDIAC ABLATION PROCEDURE WITH AN EZ STEER NAV CATHETER, THE PATIENT EXPERIENCED PERICARDIAL EFFUSION TREATED WITH REMOVAL OF 450ML OF FLUID. THE PATIENT IS STABLE. THE DAY AFTER EP STUDY FOR SUPRAVENTRICULAR TACHYCARDIA (SVT), AFTER THE PATIENT RECEIVED 2MICRO LITERS OF ISUPREL TO INDUCE AVNRT, THE PATIENT ALMOST STOOD UP OFF THE BED AS SOON AS THE ISUPREL HIT. THIS MORNING THE PHYSICIAN DRAINED 450ML FROM THE PATIENT DUE TO A PERICARDIAL EFFUSION. DISCOVERED BY THE PHYSICIAN THROUGH IMAGING. THE MEDICAL INTERVENTION PROVIDED TO THE PATIENT WAS THE DRAINING OF 450 ML OF FLUID. THE PATIENT WILL HAVE MORE IMAGING DONE LATER TODAY WITH INTERVENTIONAL AND CURRENTLY REMAINS IN STABLE CONDITION. DURING THE ADVERSE EVENT, THERE WAS A DECANAV CATHETER AND 3 QUAD CATHETERS IN THE BODY. THEY "ASSUMED THE EVENT HAPPENED WHEN THE PATIENT JUMPED OFF THE TABLE", BUT AN EZ STEER NAV CATHETER AND VIZIGO SHEATH WERE USED DURING ABLATION BUT WERE NOT IN THE BODY WHEN THE PATIENT STOOD UP. ADDITIONAL INFORMATION WAS RECEIVED. THE ADVERSE EVENT WAS DISCOVERED POST USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN BELIEVED THE EFFUSION HAPPENED DUE TO THE PROCEDURE, AND THE PATIENT MOVING SIGNIFICANTLY UPWARDS AFTER RECEIVING ISUPREL. THE PHYSICIAN PERFORMED A PERICARDIOCENTESIS AND DRAINED 450 ML OF FLUID THE MORNING AFTER THE INDEX PROCEDURE WHEN THE EVENT WAS REPORTED. SIX CATHETER EXCHANGES OCCURRED DURING THE PROCEDURE (3 BWI QUADS, 1 VIZIGO, 1 DECANAV, 1 EZ STEER NAV CATHETER). NO TRANSSEPTAL PUNCTURE WAS PERFORMED. NO EVIDENCE OF A STEAM POP, AND NO IRRIGATED CATHETER WAS USED. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. NO ISSUES WITH FLOW RATE CHANGE AT THE START OF ABLATION. NO ERROR MESSAGES WERE OBSERVED ON BWI EQUIPMENT DURING THE PROCEDURE. NO FORCE VISUALIZATION FEATURES WERE USED. A MINIMUM TIME OF 3S WAS USED AS THE VISITAG MODULE PARAMETER FOR STABILITY. NO ADDITIONAL FILTER WAS USED WITH THE VISITAG. IMPEDANCE CHANGE WAS USED AS THE COLOR OPTION FOR VISITAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1341376 EZ STEER NAV CATHETER ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Life Threatening| R CARTO® 3 -.| DECANAV® CATHETER.| NGEN¿ GENERATOR.| UNK BWI QUAD.| UNK BWI QUAD.| UNK BWI QUAD.| VIZIGO¿ SHEATH.