BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 14856818 · Received June 29, 2022

    Report

    Report Number
    2029046-2022-01472
    Event Type
    Injury
    Date Received
    June 29, 2022
    Date of Event
    April 28, 2022
    Report Date
    June 29, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: TROISI F, GUIDA P, QUADRINI F, DI MONACO A, VITULANO N, CARUSO R, ORFINO R, CECERE G, ANSELMINO M, GRIMALDI M. ZERO FLUOROSCOPY ARRHYTHMIAS CATHETER ABLATION: A TREND TOWARD MORE FREQUENT PRACTICE IN A HIGH-VOLUME CENTER. FRONT CARDIOVASC MED. 2022 APR 28;9:804424. DOI: 10.3389/FCVM.2022.804424. PMID: 35571172; PMCID: PMC9095839. NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS PROVIDED BY THE CUSTOMER. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. 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).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: TROISI F, GUIDA P, QUADRINI F, DI MONACO A, VITULANO N, CARUSO R, ORFINO R, CECERE G, ANSELMINO M, GRIMALDI M. ZERO FLUOROSCOPY ARRHYTHMIAS CATHETER ABLATION: A TREND TOWARD MORE FREQUENT PRACTICE IN A HIGH-VOLUME CENTER. FRONT CARDIOVASC MED. 2022 APR 28;9:804424. DOI: 10.3389/FCVM.2022.804424. PMID: 35571172; PMCID: PMC9095839. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND: AWARENESS OF RADIATION EXPOSURE RISKS ASSOCIATED TO INTERVENTIONAL CARDIOLOGY PROCEDURES IS GROWING. THE AVAILABILITY OF NEW TECHNOLOGIES IN ELECTROPHYSIOLOGY LABORATORIES HAS REDUCED FLUOROSCOPY USAGE DURING ARRHYTHMIAS ABLATIONS. THE AIM OF THIS STUDY WAS TO DESCRIBE PROCEDURES WITH AND WITHOUT X-RAYS AND TO ASSESS FEASIBILITY, SAFETY, AND SHORT-TERM EFFICACY OF ZERO FLUOROSCOPY INTERVENTION IN A HIGH-VOLUME CENTER ORIENTED TO KEEP EXPOSURE TO IONIZING RADIATION AS LOW AS REASONABLY ACHIEVABLE. METHODS: CARDIAC CATHETER ABLATIONS PERFORMED IN OUR HOSPITAL SINCE (B)(6) 2017 TO (B)(6) 2021. RESULTS: A TOTAL OF 1,853 PROCEDURES WERE PERFORMED WITH 1,957 ARRHYTHMIAS TREATED. RATE OF FLUOROLESS PROCEDURES WAS 15.4% (285 INTERVENTIONS) WITH AN INCREASING TREND FROM 8.5% IN 2017 TO 22.9% OF FIRST SEMESTER 2021. THE MOST FREQUENT ARRHYTHMIA TREATED WAS ATRIAL FIBRILLATION (646; 3.6% FLUOROLESS) FOLLOWED BY ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (644; 16.9% FLUOROLESS), ATRIAL FLUTTER (215; 8.8% FLUOROLESS), VENTRICULAR TACHYCARDIA (178; 17.4% FLUOROLESS), PREMATURE VENTRICULAR CONTRACTION (162; 48.1% FLUOROLESS), AND ACCESSORY PATHWAYS (112; 31.3% FLUOROLESS). ALTHOUGH CHARACTERISTICS OF PATIENTS AND OPERATIVE DETAILS WERE HETEROGENEOUS AMONG TREATED ARRHYTHMIAS, USE OF FLUOROSCOPY DID NOT INFLUENCE PROCEDURE DURATION. MOREOVER, FEASIBILITY AND EFFICACY WERE 100% IN FLUOROLESS ABLATIONS WHILE THE RATE OF MAJOR COMPLICATIONS WAS VERY LOW AND NO DIFFERENT WITH OR WITHOUT FLUOROSCOPY (0.45 VS. 0.35%). CONCLUSION: LIMITING THE USE OF X-RAYS IS NECESSARY, ESPECIALLY WHEN THE AVAILABLE TECHNOLOGIES ALLOW A ZERO-USE APPROACH. A LOWER RADIATION EXPOSURE MAY BE REACHED, REDUCING FLUOROSCOPY USAGE WHENEVER POSSIBLE DURING CARDIAC ABLATION PROCEDURES WITH HIGH SAFETY, FULL FEASIBILITY, AND EFFICACY. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH. OTHER BIOSENSE WEBSTER CONCOMITANT DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO3, DECANAV. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: THERE WERE A TOTAL OF SIX ADVERSE EVENTS REPORTED IN THIS LITERATURE ARTICLE: (3) PERICARDIAL EFFUSIONS WITHOUT CARDIAC TAMPONADE. (3) PATIENTS HAD CARDIAC TAMPONADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2366320 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| L CARTO3| DECANAV