BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 15317657 · Received August 30, 2022

    Report

    Report Number
    2029046-2022-02035
    Event Type
    Injury
    Date Received
    August 30, 2022
    Date of Event
    May 25, 2022
    Report Date
    August 29, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF NO: (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITATION HAS BEEN REVIEWED: SCHLEBERGER R, RIESS J, BRAUER A, PINNSCHMIDT HO, ROTTNER L, MOSER F, MOSER J, KANY S, MY I, LEMOINE MD, REISSMANN B, MEYER C, METZNER A, OUYANG F, KIRCHHOF P, RILLIG A. ABLATION OF OUTFLOW TRACT ARRHYTHMIAS IN PATIENTS WITH AND WITHOUT STRUCTURAL HEART DISEASE-A COMPARATIVE ANALYSIS. FRONT CARDIOVASC MED. 2022 MAY 25;9:910042. DOI: 10.3389/FCVM.2022.910042. PMID: 35694678; PMCID: PMC9174508. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS NOT 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITATION HAS BEEN REVIEWED: SCHLEBERGER R, RIESS J, BRAUER A, PINNSCHMIDT HO, ROTTNER L, MOSER F, MOSER J, KANY S, MY I, LEMOINE MD, REISSMANN B, MEYER C, METZNER A, OUYANG F, KIRCHHOF P, RILLIG A. ABLATION OF OUTFLOW TRACT ARRHYTHMIAS IN PATIENTS WITH AND WITHOUT STRUCTURAL HEART DISEASE-A COMPARATIVE ANALYSIS. FRONT CARDIOVASC MED. 2022 MAY 25;9:910042. DOI: 10.3389/FCVM.2022.910042. PMID: 35694678; PMCID: PMC9174508. OBJECTIVE/METHODS/STUDY DATA: : CONSECUTIVE PATIENTS (2019¿2021) UNDERGOING CATHETER ABLATION OF VENTRICULAR ARRHYTHMIAS IN A SINGLE HIGH-VOLUME CENTER WERE RETROSPECTIVELY ANALYZED - 215 PATIENTS WITH OUTFLOW TRACT ARRHYTHMIAS (35.3% FEMALE, MEAN AGE 58.3 ± 16.0 YEARS). THE ARTICLE MENTIONS A DEATH THAT WAS DUE TO PROGRESSIVE HEART FAILURE AND NOT STATED TO BE RELATED TO THE DEVICE. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: A STEERABLE SINGLE-TIP ABLATION CATHETER (THERMOCOOL, D- OR F-TYPE,2-5-2 MM SPACING). OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO 3, PENTARAY NAV CATHETER. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: QTY UNK 0.5% PERICARDIAL TAMPONADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134180 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening CARTO 3| PENTARAY NAV CATHETER