BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 20182400 · Received September 10, 2024

    Report

    Report Number
    2029046-2024-03010
    Event Type
    Malfunction
    Date Received
    September 10, 2024
    Date of Event
    August 13, 2024
    Report Date
    October 7, 2024
    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

    D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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 13-SEP-2024, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE PRODUCT INVESTIGATION WAS SUBSEQUENTLY COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND THE DEVICE (INCLUDING PORT, LUER HUB) WAS NOT IRRIGATING. THE PUMP DID NOT HAVE ANY PROBLEMS, BUT THE TEMPERATURE WAS HIGH DURING DISCHARGE. AFTER WITHDRAWAL, IT WAS FOUND THAT THE CONDUIT COULD NOT FLUSH. THE CATHETER WAS SUSPECTED AS THE ISSUE DURING THE EVENT. THE ISSUE WAS NOTED AFTER THE DEVICE WAS USED ON THE PATIENT. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. DEVICE EVALUATION DETAILS: IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND THE DEVICE (INCLUDING PORT, LUER HUB) WAS NOT IRRIGATING. THE PUMP DID NOT HAVE ANY PROBLEMS, BUT THE TEMPERATURE WAS HIGH DURING DISCHARGE. AFTER WITHDRAWAL, IT WAS FOUND THAT THE CONDUIT COULD NOT FLUSH. THE CATHETER WAS SUSPECTED AS THE ISSUE DURING THE EVENT. THE ISSUE WAS NOTED AFTER THE DEVICE WAS USED ON THE PATIENT. 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 FOR EVALUATION. A VISUAL INSPECTION, TEMPERATURE, IMPEDANCE AND IRRIGATION TESTS OF THE RETURNED DEVICE WERE PERFORMED IN ACCORDANCE WITH J&J MEDTECH PROCEDURES. VISUAL ANALYSIS REVEALED REDDISH MATERIAL IN THE LUER HUB, NO OTHER DAMAGE OR ANOMALIES WERE OBSERVED ON THE DEVICE. TEMPERATURE AND IMPEDANCE TESTS WERE PERFORMED AND THE TEMPERATURE WAS HIGH. AN IRRIGATION TEST WAS PERFORMED AND THE DEVICE WAS NOT FLUSHING CORRECTLY. THE IRRIGATION TUBE WAS OBSERVED OCCLUDED WITH REDDISH MATERIAL INSIDE THE SHAFT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31334965M AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. THE HIGH TEMPERATURE AND IRRIGATION ISSUES REPORTED BY THE CUSTOMER WERE CONFIRMED DUE TO THE OCCLUSION OF THE IRRIGATION TUBE WHICH COULD CAUSE THE HIGH TEMPERATURE VALUES DURING THE PROCEDURE. THE POTENTIAL CAUSE OF THE REDDISH MATERIAL AT THE LUER HUB AND OCCLUSION OF THE IRRIGATION TUBE COULD BE RELATED TO THE PROCEDURE. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING RECOMMENDATIONS: FLUSH THE CATHETER AND THE TUBING PER STANDARD TECHNIQUE TO ENSURE PURGING OF TRAPPED AIR BUBBLES AND TO VERIFY THAT THE IRRIGATION HOLES ARE PATENT; INSPECT THE IRRIGATION SALINE FOR AIR BUBBLES PRIOR TO ITS USE IN THE PROCEDURE; MAKE SURE THE IRRIGATION HOLES ARE NOT PLUGGED PRIOR TO REINSERTION; WHEN RF CURRENT IS INTERRUPTED FOR EITHER A TEMPERATURE OR AN IMPEDANCE RISE (THE SET LIMIT IS EXCEEDED), THE CATHETER SHOULD BE REMOVED, AND THE TIP CLEANED. MAKE SURE THE IRRIGATION HOLES ARE NOT PLUGGED PRIOR TO RE-INSERTION. 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 CARDIAC ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND THE DEVICE (INCLUDING PORT, LUER HUB) WAS NOT IRRIGATING. THE PUMP DID NOT HAVE ANY PROBLEMS, BUT THE TEMPERATURE WAS HIGH DURING DISCHARGE. AFTER WITHDRAWAL, IT WAS FOUND THAT THE CONDUIT COULD NOT FLUSH. THE CATHETER WAS SUSPECTED AS THE ISSUE DURING THE EVENT. THE ISSUE WAS NOTED AFTER THE DEVICE WAS USED ON THE PATIENT. 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
    2335440 NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER INC 31334965M 10846835000559

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown