BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 22982859 · Received September 5, 2025

    Report

    Report Number
    2029046-2025-03026
    Event Type
    Malfunction
    Date Received
    September 5, 2025
    Date of Event
    August 11, 2025
    Report Date
    October 1, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAD
    UDI-DI
    10846835000559
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A VIDEO WAS RECEIVED FOR EVALUATION FOLLOWING JOHNSON & JOHNSON MEDTECH'S PROCEDURES. ACCORDING TO VIDEO PROVIDED BY THE CUSTOMER, THE CATHETER WAS FLUSHED WITH A SYRINGE; HOWEVER, NO FLOW WAS OBSERVED THROUGH THE IRRIGATION HOLE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31649949M AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE BWI 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. 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

    ON 10-SEP-2025, THE PRODUCT INVESTIGATION WAS COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR REENTRANT TACHYCARDIA / WOLFF-PARKINSON-WHITE (WPW) SYNDROME ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND THE DEVICE (INCLUDING PORT, LUER HUB) WAS NOT IRRIGATING. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. VISUAL INSPECTION AND IRRIGATION TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING J&J MEDTECH PROCEDURES. VISUAL ANALYSIS REVEALED REDDISH MATERIAL IN THE LUER HUB. AN IRRIGATION TEST WAS PERFORMED, AND THE CATHETER FAILED THE TEST DUE TO THE IRRIGATION TUBE WAS FOUND BENT AT THE SHAFT AREA. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31649949M AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE IRRIGATION ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE POTENTIAL CAUSE OF THE IRRIGATION TUBE BENT COULD NOT BE CONCLUSIVELY DETERMINED. THE REDDISH MATERIAL OBSERVED IN THE LUER HUB IS RELATED TO THE PROCEDURE. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING RECOMMENDATIONS: PURGE THE CATHETER AND THE IRRIGATION TUBING WITH HEPARINIZED NORMAL SALINE PRIOR TO INSERTION OF THE CATHETER INTO THE PATIENT. AS PART OF JOHNSON & JOHNSON MEDTECH'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH J&J MEDTECH'S QUALITY SYSTEM. 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 AN ATRIOVENTRICULAR REENTRANT TACHYCARDIA / WOLFF-PARKINSON-WHITE (WPW) SYNDROME ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND THE DEVICE (INCLUDING PORT, LUER HUB) WAS NOT IRRIGATING. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2226115 NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER INC 31649949M 10846835000559

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown