BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 19823167 · Received July 24, 2024

    Report

    Report Number
    2029046-2024-02495
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Date of Event
    June 20, 2024
    Report Date
    August 28, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009774
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: THE EXPIRATION DATE AND MANUFACTURE DATE ARE 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

    D4 PRIMARY UDI NUMBER HAS BEEN UPDATED TO (B)(4). ON 2-AUG-2024, THE PRODUCT INVESTIGATION WAS COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND THE CATHETER WOULD NOT FLUSH. THE ISSUE WAS DISCOVERED WHEN A TEMPERATURE ERROR OCCURRED ON THE IRRIGATION PUMP. THIS WAS NOTED AFTER ONE APPLICATION ON THE PATIENT. THE CATHETER WAS REMOVED FROM THE BODY AND THERE WAS NO CHAR. THERE WERE NO VISUAL OBSTRUCTIONS TO THE CATHETER, ONLY AN ABUNDANCE OF PRESSURE IN THE TUBING, AND WHEN THE MEDICAL TEAM TURNED THE FLOW OFF OF THE PATIENT THE SOLUTION SPEWED OUT OF THE OPEN PORT ONTO THE SCREEN. THE MEDICAL TEAM FLUSHED THE CAHTETER SEVERAL TIMES WITH NO RESOLUTION. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THE PUMP WAS ALSO FUNCTIONING CORRECTLY AND ABLE TO NAVIGATE BETWEEN LOW AND HIGH FLOW. WHEN THE CATHETER WAS REPLACED, THE ISSUE WAS RESOLVED. THE PROCEDURE WAS CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. A VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. A PUMP AND PRESSURE GAGE TEST WAS PERFORMED, AND THE DEVICE WAS IRRIGATING CORRECTLY. NO IRRIGATION ISSUES WERE OBSERVED. ALSO, A TEMPERATURE AND IMPEDANCE TEST WAS PERFORMED: NO TEMPERATURE OR IMPEDANCE ISSUES WERE DETECTED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 31265830L, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. THE OCCLUSION/NO IRRIGATION ISSUE REPORTED BY THE CUSTOMER COULD NOT BE REPLICATED DURING THE PRODUCT INVESTIGATION; OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USAGE OF THE DEVICE THAT COMPROMISED ITS PERFORMANCE. 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 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 AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND THE CATHETER WOULD NOT FLUSH. THE ISSUE WAS DISCOVERED WHEN A TEMPERATURE ERROR OCCURRED ON THE IRRIGATION PUMP. THIS WAS NOTED AFTER ONE APPLICATION ON THE PATIENT. THE CATHETER WAS REMOVED FROM THE BODY AND THERE WAS NO CHAR. THERE WERE NO VISUAL OBSTRUCTIONS TO THE CATHETER, ONLY AN ABUNDANCE OF PRESSURE IN THE TUBING, AND WHEN THE MEDICAL TEAM TURNED THE FLOW OFF OF THE PATIENT THE SOLUTION SPEWED OUT OF THE OPEN PORT ONTO THE SCREEN. THE MEDICAL TEAM FLUSHED THE CAHTETER SEVERAL TIMES WITH NO RESOLUTION. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THE PUMP WAS ALSO FUNCTIONING CORRECTLY AND ABLE TO NAVIGATE BETWEEN LOW AND HIGH FLOW. WHEN THE CATHETER WAS REPLACED, THE ISSUE WAS RESOLVED. THE PROCEDURE WAS CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2370980 THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31265830L 10846835009774

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CARTO 3 SYSTEM| NGEN GENERATOR