BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 16457646 · Received February 28, 2023

    Report

    Report Number
    2029046-2023-00409
    Event Type
    Injury
    Date Received
    February 28, 2023
    Date of Event
    January 5, 2023
    Report Date
    February 28, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010145
    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:PAPPONE C, CICONTE G, ANASTASIA L, GAITA F, GRANT E, MICAGLIO E, LOCATI ET, CALOVIC Z, VICEDOMINI G, SANTINELLI V. RIGHT VENTRICULAR EPICARDIAL ARRHYTHMOGENIC SUBSTRATE IN LONG-QT SYNDROME PATIENTS AT RISK OF SUDDEN DEATH. EUROPACE. 2023 JAN 5:EUAC264. DOI: 10.1093/EUROPACE/EUAC264. EPUB AHEAD OF PRINT. PMID: 36610790. 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 NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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 REF #: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED:PAPPONE C, CICONTE G, ANASTASIA L, GAITA F, GRANT E, MICAGLIO E, LOCATI ET, CALOVIC Z, VICEDOMINI G, SANTINELLI V. RIGHT VENTRICULAR EPICARDIAL ARRHYTHMOGENIC SUBSTRATE IN LONG-QT SYNDROME PATIENTS AT RISK OF SUDDEN DEATH. EUROPACE. (B)(6) 2023:EUAC264. DOI: 10.1093/EUROPACE/EUAC264. EPUB AHEAD OF PRINT. PMID: 36610790. OBJECTIVE/METHODS/STUDY DATA: OBJECTIVE THE AIM OF THIS STUDY WAS TO ASSESS THE PRESENCE OF AN UNDERLYING ELECTROANATOMICAL ARRHYTHMOGENIC SUBSTRATE IN HIGH-RISK LQTS PATIENTS. THE PRESENT STUDY ENROLLED 11 CONSECUTIVE LQTS PATIENTS WHO HAD EXPERIENCED FREQUENT IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD DISCHARGES TRIGGERED BY VENTRICULAR FIBRILLATION (VF). WE ACQUIRED ELECTROANATOMICAL BIVENTRICULAR MAPS OF BOTH ENDO AND EPICARDIAL REGIONS FOR ALL PATIENTS AND ANALYZED ELECTROGRAMS SAMPLED FROM SEVERAL MYOCARDIAL REGIONS. ABNORMAL ELECTRICAL ACTIVITIES WERE TARGETED AND ELIMINATED BY THE MEANS OF RADIOFREQUENCY CATHETER ABLATION. VF EPISODES CAUSED A MEDIAN OF FOUR ICD DISCHARGES IN ELEVEN PATIENTS (6 MALE, 54.5%; MEAN AGE 44.0±7.8 YEARS, RANGE 22¿53) PRIOR TO OUR MAPPING AND ABLATION PROCEDURES. THE AVERAGE QTC INTERVAL WAS 500.0± 30.2 MS. ENDO-EPICARDIAL BIVENTRICULAR MAPS DISPLAYED ABNORMALLY FRAGMENTED, LOW-VOLTAGE (0.9±0.2 MV) AND PROLONGED ELECTROGRAMS (89.9±24.1 MS) EXCLUSIVELY LOCALIZED IN THE RIGHT VENTRICULAR EPICARDIUM. WE FOUND ELECTRICAL ABNORMALITIES EXTENDING OVER A MEAN EPICARDIAL AREA OF 15.7±3.1 CM2. CATHETER ABLATION OF THE ABNORMAL EPICARDIAL AREA COMPLETELY SUPPRESSED MALIGNANT ARRHYTHMIAS OVER A MEAN 12 MONTHS OF FOLLOW-UP (MEDIAN VF EPISODES BEFORE VS. AFTER ABLATION, 4 VS. 0; P=0.003). AFTER THE PROCEDURE, THE QTC INTERVAL MEASURED IN A 12-LEAD ECG ANALYSIS SHORTENED TO A MEAN OF 461.8±23.6 MS (P=0.004). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS:THERMOCOOL SMARTTOUCH SF FOR ABLATION CATHETER OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO 3 FOR MAPPING AND ABLATION, DECANAV MAPPING CATHETERS NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: QTY 1 PATIENT EXPERIENCED PERICARDIAL EFFUSION 2 WEEKS POST PROCEDURE AND REQUIRED SUCCESSFUL PERICARDIOCENTESIS WITHOUT RECURRENCE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1147452 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134801 10846835010145

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R CARTO 3 FOR MAPPING AND ABLATION| DECANAV MAPPING CATHETERS