BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 19383428 · Received May 23, 2024

    Report

    Report Number
    2029046-2024-01685
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Date of Event
    April 25, 2024
    Report Date
    June 26, 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

    E 1. INITIAL REPORTER ADDRESS LINE 1 (CONT.): (B)(6). 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 CARDIAC ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND BEFORE THE OPERATION, THE DEVICE (INCLUDING PORT, LUER HUB) WAS NOT IRRIGATING. THERE WAS NO ERROR NOTED FROM THE IRRIGATION PUMP. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THE PUMP WAS SWITCHING FROM ¿LOW¿ TO ¿HIGH¿ FLOW DURING ABLATION. 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 BIOSENSE WEBSTER FOR EVALUATION. A VISUAL INSPECTION, AND IRRIGATION TEST OF THE RETURNED DEVICE WERE PERFORMED IN ACCORDANCE WITH BWI PROCEDURES. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THERE WAS A BIG BENT IN THE SHAFT CLOSE TO THE HANDLE AREA. AN IRRIGATION TEST WAS PERFORMED, AND THE CATHETER WAS NOT COMPLETELY OCCLUDED, BUT THE FLOW WAS VERY WEAK. THEN, THE CATHETER HANDLE WAS DISSECTED, AND THE IRRIGATION TUBE WAS FOUND FOLDED INSIDE THE SHAFT. THE DAMAGE ON THE SHAFT IS DIRECTLY RELATED TO THE FOLDED IRRIGATION TUBE AND COULD BE CAUSED BY THE MANIPULATION OF THE DEVICE BEFORE THE PROCEDURE. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31231018M, 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 FOLDED IRRIGATION TUBE COULD NOT BE ESTABLISHED. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING WARNING AND PRECAUTIONS: PURGE THE CATHETER AND THE IRRIGATION TUBING WITH HEPARINIZED NORMAL SALINE PRIOR TO INSERTION OF THE CATHETER INTO THE PATIENT. INSPECT THE IRRIGATION SALINE FOR AIR BUBBLES PRIOR TO ITS USE IN THE PROCEDURE. AIR BUBBLES IN THE IRRIGATION SALINE MAY CAUSE EMBOLI. ALWAYS MAINTAIN A CONSTANT HEPARINIZED NORMAL SALINE INFUSION TO PREVENT COAGULATION WITHIN THE LUMEN OF THE CATHETER. DO NOT MANUALLY PRE-SHAPE THE DISTAL SHAFT OF THE CATHETER BY APPLYING EXTERNAL FORCES INTENDED TO BEND OR AFFECT THE INTENDED SHAPE OR CURVE OF THE CATHETER. AS PART OF BIOSENSE WEBSTER'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 BEFORE THE OPERATION, THE DEVICE (INCLUDING PORT, LUER HUB) WAS NOT IRRIGATING. THERE WAS NO ERROR NOTED FROM THE IRRIGATION PUMP. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THE PUMP WAS SWITCHING FROM ¿LOW¿ TO ¿HIGH¿ FLOW DURING ABLATION. 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
    604349 NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER INC 31231018M 10846835000559

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNK GENERATOR.| UNK PUMP.