BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARIPULSE¿ BI-DIRECTIONAL CATHETER

    MDR report key: 24492056 · Received March 2, 2026

    Report

    Report Number
    2029046-2026-00693
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Date of Event
    February 4, 2026
    Report Date
    April 13, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    QZI
    UDI-DI
    10846835025460
    PMA / PMN Number
    P240006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION 25-FEB-2026. 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. 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).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH A VARIPULSE¿ BI-DIRECTIONAL CATHETER. CATHETER NOT VISUALIZED PROPERLY, MAGNETIC DISTORTION AND CATHETER NOT VISIBLE ON THE SUPERIOR PART OF THE ATRIUM. THEY CHANGED THE CABLE BUT NOT ABLATION CATHETER. DID NOT SOLVE THE ISSUE. ADDITIONALLY, THE IRRIGATION WAS NOT GOING THROUGH THE TUBING GOT BIGGER AND IRRIGATION STOPPED. THE DEVICE EVALUATION WAS COMPLETED ON 20-MAR-2026. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION, IRRIGATION TEST AND MAGNETIC SENSOR FUNCTIONALITY TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL INSPECTION REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. AN IRRIGATION TEST WAS PERFORMED, AND THE DEVICE WAS IRRIGATED CORRECTLY. THE DEVICE WAS CONNECTED TO THE CARTO 3 SYSTEM AND IT WAS RECOGNIZED AND VISUALIZED CORRECTLY. NO MAGNETIC SENSOR ERROR OR FAILURES WERE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE MAGNETIC SENSOR ERROR AND IRRIGATION ISSUE REPORTED BY THE CUSTOMER COULD NOT BE REPLICATED DURING THE PRODUCT INVESTIGATION; OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USE OF THE DEVICE THAT MAY HAVE AFFECTED ITS PERFORMANCE. THE CARTO® 3 SYSTEM INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING INFORMATION: THE MAGNETIC SENSOR OF THE CATHETER IS DISCONNECTED. TO CONTINUE, REPLACE THE CATHETER CABLE. IF THAT DOES NOT RESOLVE THE PROBLEM, REPLACE THE CATHETER. AS PART OF JOHNSON & JOHNSON MEDTECH¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH A VARIPULSE¿ BI-DIRECTIONAL CATHETER AND OBSERVED AN IRRIGATION ISSUE (DEVICE USED IN PATIENT). CATHETER NOT VISUALIZED PROPERLY, MAGNETIC DISTORTION AND CATHETER NOT VISIBLE ON THE SUPERIOR PART OF THE ATRIUM. THEY CHANGED THE CABLE BUT NOT ABLATION CATHETER. DID NOT SOLVE THE ISSUE. ADDITIONALLY, THE IRRIGATION WAS NOT GOING THROUGH THE TUBING GOT BIGGER AND IRRIGATION STOPPED. CATHETER CHANGED AND IRRIGATION ISSUE FIXED (NOT VISUALIZATION ISSUE). THE PROCEDURE WAS DELAYED DUE TO THE REPORTED EVENT FOR 5 MINUTES. THE PROCEDURE WAS COMPLETELY SUCCESSFULLY. NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED. TEN PFA APPLICATIONS/ABLATIONS WERE COMPLETED BEFORE THIS ISSUE OCCURRED. THE ISSUE WAS NOTED DURING THE DEVICE WAS USED ON THE PATIENT. THE NGEN PUMP, EU CONFIGURATION /(D139701) WAS USED. ISSUE NOTED FROM THE IRRIGATION PUMP, BUT THE ISSUE MIGHT HAVE HAPPENED ALREADY FROM EARLIER. THE IRRIGATION WENT THROUGH THE PUMP BUT NOT OUTSIDE THE CATHETER. THE IRRIGATION TUBING GOT ENLARGED. STEPS TAKEN TO RESOLVE THE IRRIGATION ISSUE WERE TO SWITCH THE CATHETER AND CHECKED PROPER IRRIGATION FROM THE NEW CATHETER. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. ALTHOUGH WE NEED TO USE THE NGEN PUMP FOR THE IRRIGATION TO DO THE 30 ML/MIN DURING ABLATION (LOW FLOW 4 ML MIN AND HIGH FLOW 30 ML MIN). THE MAGNETIC DISTORTION ISSUE WAS ASSESSED AS NON MDR REPORTABLE. THE INCIDENCE OF MAGNETIC SENSOR ERROR WAS EASY DETECTABLE BY THE USER. THE CATHETER WAS INOPERABLE, SINCE IT CANNOT BE VISUALIZED ON THE CARTO SYSTEM. THE USER WILL HAVE TO REPLACE THE CATHETER. THE MOST LIKELY CONSEQUENCE WAS AN INTRAPROCEDURAL DELAY. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH WAS REMOTE. THE IRRIGATION ISSUE (DEVICE USED IN PATIENT) WAS ASSESSED AS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410777 VARIPULSE¿ BI-DIRECTIONAL CATHETER PERCUTANEOUS CARDIAC ABL CATH FOR TREATMT OF AFIB W IRREVERSIBLE ELECTROPORATION QZI BIOSENSE WEBSTER INC 31687112L 10846835025460

    Patients

    Seq Age Sex Outcome Treatment
    1