BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 17406270 · Received July 27, 2023

    Report

    Report Number
    2029046-2023-01613
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Date of Event
    June 30, 2023
    Report Date
    September 11, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009262
    PMA / PMN Number
    P030031/S034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER AND BLOOD CLOTS/THROMBUS WERE DISCOVERED. DURING AN ATRIAL FLUTTER ABLATION, CATHETER WAS PROPERLY FLUSHED PRIOR TO INSERTION WITH FLOW RUNNING AT 2ML/MIN AS PER THE AUTOMATED SETTINGS. UPON ABLATION, TEMPERATURE WAS RISING AND RF STOPPED. DECISION TO REMOVE CATHETER AND CHECK IRRIGATION. IRRIGATION WAS BLOCKED. CATHETER REPLACED. PATIENT SEEMED TO BE CLOTTING, FEW CLOTS OBSERVED INSIDE THE SHEATHS. THE SURGERY WAS NOT DELAYED AND COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. ON 21-AUG-2023, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THAT DURING THIS PROCEDURE, NO BWI SHEATH WAS USED. DEVICE INVESTIGATION DETAILS: SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 30826509L AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. NOTE: H6. MEDICAL DEVICE PROBLEM CODE HAS BEEN CORRECTED FROM DEVICE CONTAMINATION WITH BODY FLUID (A180103) TO COAGULATION IN DEVICE OR DEVICE INGREDIENT (A030202). IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    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. 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 A THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER AND BLOOD CLOTS/THROMBUS WERE DISCOVERED. DURING AN ATRIAL FLUTTER ABLATION, CATHETER WAS PROPERLY FLUSHED PRIOR TO INSERTION WITH FLOW RUNNING AT 2ML/MIN AS PER THE AUTOMATED SETTINGS. UPON ABLATION, TEMPERATURE WAS RISING AND RF STOPPED. DECISION TO REMOVE CATHETER AND CHECK IRRIGATION. IRRIGATION WAS BLOCKED. CATHETER REPLACED. PATIENT SEEMED TO BE CLOTTING, FEW CLOTS OBSERVED INSIDE THE SHEATHS. THE SURGERY WAS NOT DELAYED AND COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THE THROMBUS WAS FOUND WHILE RINSING THE SHEATH WHEN EXCHANGING CATHETERS. THERE WERE NO ERROR MESSAGES OR PRODUCT PROBLEMS. ISSUES RELATED TO TEMPERATURE WERE ENCOUNTERED AS THE FLOW WAS BLOCKED WITHIN THE CATHETER WHILE DELIVERING THE RF. THE TEMPERATURE WAS RISING AND THE RF WAS STOPPED DUE TO HIGH TEMPERATURE. THE NGEN GENERATOR WAS SET TO POWER CONTROL, 35WATTS. TEMP NOTED AROUND 40 DÉGREES. IMPEDANCE 110, 35 WATTS AND BELOW DUE TO HIGH TEMPERATURE. NO ACTIVATED CLOTTING TIME (ACT), PROCEDURE WAS RIGHT SIDED. THE PHYSICIAN CONSIDERED THE AMOUNT OF THROMBUS/CLOT TO BE EXCESSIVE BUT NOT RELATED TO DEVICE OR ITS UTILIZATION AND NOT A RISK TO THE PATIENT. THE PATIENT HAS NOT EXHIBITED ANY NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE. A NGEN PUMP WAS ALSO USED IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662828 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 30826509L 10846835009262

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NGEN PUMP, EU CONFIGURATION.| NGEN RF GENERATOR.| UNKNOWN SHEATH.