BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ STEER

    MDR report key: 23483383 · Received November 5, 2025

    Report

    Report Number
    2029046-2025-03732
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    October 14, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835002515
    PMA / PMN Number
    P950005/S19
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 4-NOV-2025, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. 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. 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 REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH AN EZ STEER CATHETER AND THE TIP APPEARED DAMAGED WHICH EXPOSED INTERNAL COMPONENTS. DEVICE INVESTIGATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J) FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING J&J PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. THE TIP WAS OBSERVED WITHOUT PROBLEMS, NO BROKEN OR SEPARATION CONDITION WERE OBSERVED. IN ADDITION, MICROSCOPIC EXAMINATION OF THE TIP WAS PERFORMED AND NO WIRE OR COMPONENT EXPOSED WERE IDENTIFIED. THE TIP ISSUE REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USAGE OF THE DEVICE THAT COMPROMISED ITS PERFORMANCE. THE INSTRUCTIONS FOR USE CONTAIN (IFU) THE FOLLOWING RECOMMENDATIONS: DO NOT SCRUB OR TWIST THE DISTAL TIP ELECTRODE DURING CLEANING. DO NOT USE EXCESSIVE FORCE TO ADVANCE OR WITHDRAW THE CATHETER WHEN RESISTANCE IS ENCOUNTERED DURING CATHETER MANIPULATION THROUGH THE SHEATH. IN ORDER TO PREVENT DAMAGE TO THE CATHETER TIP, USE THE INSERTION TUBE SUPPLIED WITH THE CATHETER TO ADVANCE OR RETRACT THE CATHETER THROUGH THE HEMOSTASIS VALVE OF THE SHEATH. AFTER INSERTION, SLIDE THE INSERTION TUBE BACK TOWARD THE HANDLE. 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 REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH AN EZ STEER CATHETER AND THE TIP APPEARED DAMAGED WHICH EXPOSED INTERNAL COMPONENTS. IT WAS REPORTED THAT THERE WAS 60 HZ NOISE DISPLAYED ON THE DISTAL ABLATION CATHETER SIGNAL, DISPLAYED ON THE ABBOTT EP RECORDING SYSTEM. THIS WAS A NON-NAVIGATIONAL A-V NODE ABLATION WITH THE NGEN¿ RF GENERATOR. THEY REMOVED THE CATHETER FROM THE PATIENT AND NOTICED THE TIP APPEARED TO BE DAMAGED, EXPOSING INTERNAL COMPONENTS. THEY OPENED A REPLACEMENT CATHETER (DIFFERENT LOT) AND THE SECOND CATHETER HAD THE SAME ISSUE WITH DAMAGED TIP, NOTICED PRIOR TO PATIENT INSERTION. THEY OPENED A THIRD CATHETER (NORMAL TIP), BUT THE NOISE WAS STILL PRESENT ON THE RECORDING SYSTEM. THEY REPLACED THE CABLE FROM CATHETER TO GENERATOR (BOTH WERE NEW, NON-REPROCESSED), WITHOUT RESOLUTION. THEY REPLACED THE ABBOT PIN BLOCK THAT THE PIN CABLE FROM GENERATOR WAS CONNECTED TO, WITHOUT RESOLUTION. THE ISSUE REMAINED UNRESOLVED. THE ISSUE WAS FOUND NEAR THE PROXIMAL ELECTRODES. THERE WAS NO OTHER PHYSICAL DAMAGE. THERE WAS NO DIFFICULTY EXPERIENCE WHILE MANEUVERING THE CATHETER OR DURING WITHDRAWAL. THE ISSUE OF TIP DAMAGE WITH INTERNAL COMPONENTS EXPOSED WILL BE REPORTED AS PRODUCT MALFUNCTION AGAINST TWO (2) EZ STEER CATHETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2487487 EZ STEER ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION LPB BIOSENSE WEBSTER INC 31664464M 10846835002515

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 4MM NON-NAVIGATIONAL.| 4MM NON-NAVIGATIONAL.| ABBOTT AGILIS SHEATH.| ABBOTT EP RECORDING SYSTEM.| FOCAL CATH TO GEN STERILE CBL.| FOCAL CATH TO GEN STERILE CBL.| NGEN RF GENERATOR, US.