BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 15666309 · Received October 25, 2022

    Report

    Report Number
    2029046-2022-02631
    Event Type
    Injury
    Date Received
    October 25, 2022
    Date of Event
    February 16, 2022
    Report Date
    October 25, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITATION HAS BEEN REVIEWED: SOUSA PA, PUGA L, ADÃO L, PRIMO J, KHOUEIRY Z, LEBREIRO A, FONSECA P, LAGRANGE P, ELVAS L, GONÇALVES L. TWO YEARS AFTER PULMONARY VEIN ISOLATION GUIDED BY ABLATION INDEX-A MULTICENTER STUDY. J ARRHYTHM. 2022 MAR 15;38(3):346-352. DOI: 10.1002/JOA3.12696. PMID: 35785367; PMCID: PMC9237314. 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. THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER APPROVED UNDER PMA # P030031/S053. 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 CITATION HAS BEEN REVIEWED: SOUSA PA, PUGA L, ADÃO L, PRIMO J, KHOUEIRY Z, LEBREIRO A, FONSECA P, LAGRANGE P, ELVAS L, GONÇALVES L. TWO YEARS AFTER PULMONARY VEIN ISOLATION GUIDED BY ABLATION INDEX-A MULTICENTER STUDY. J ARRHYTHM. 2022 MAR 15;38(3):346-352. DOI: 10.1002/JOA3.12696. PMID: 35785367; PMCID: PMC9237314. OBJECTIVE/METHODS/STUDY DATA: AUTHOR AIMED TO EVALUATE THE 2-YEAR OUTCOMES AFTER A STANDARDIZED ABLATION INDEX (AI) AI-GUIDED PULMONARY VEIN ISOLATION (PVI). PROSPECTIVE, MULTICENTER STUDY OF CONSECUTIVE PATIENTS REFERRED FOR PAROXYSMAL AF ABLATION FROM JANUARY 2018 TO JULY 2019 IN FOUR TERTIARY HOSPITALS. ALL CENTERS PERFORM MORE THAN 150 AF ABLATIONS PER YEAR. ACUTE RECONNECTION (AFTER ADENOSINE TRIAL) AND 2-YEAR ARRHYTHMIA RECURRENCE RATE WERE ASSESSED. THIS PROSPECTIVE, MULTICENTER STUDY AIMED TO EVALUATE IF A TAILORED AI WITH CONTIGUOUS INTER-LESION DISTANCE (ILD) =6 MM REMAINS EFFECTIVE AT 2 YEARS OF FOLLOW-UP. THE STUDY INCLUDED 218 (842 PV) PATIENTS (61% MALES, MEDIAN AGE OF 60 [IQR 49¿68] YEARS) WITH PAROXYSMAL AF. FIRST-PASS ISOLATION WAS OBTAINED IN 93% OF THE PATIENTS, WITH AN ACUTE RECONNECTION OCCURRING IN 10.6% OF THE PATIENTS (3.2% OF THE PV)FOLLOWING ADENOSINE TRIAL. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH® IRRIGATED TIP CONTACT FORCE-SENSING RF ABLATION CATHETER (BIOSENSE WEBSTER, INC. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: LASSO® NAV ECO, BIOSENSE WEBSTER, CARTO VISITAG¿ NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: QTY 1 PHRENIC NERVE PALSY- FULL RECOVERY DURING THE FIRST 6 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2657499 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other CARTO VISITAG¿| LASSO® NAV ECO