BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 15656773 · Received October 23, 2022

    Report

    Report Number
    2029046-2022-02609
    Event Type
    Injury
    Date Received
    October 23, 2022
    Date of Event
    May 7, 2022
    Report Date
    October 23, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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: JIANG R, CHEN M, FAN J, YI F, TANG A, LIU X, ZHU W, LIU S, HUANG X, LIU Q, JU W, ZHANG X, LI J, HE J, SHI L, ZHOU G, WANG Y, FU G, JIANG C. EFFICACY OF ABLATION INDEX-GUIDED PULMONARY VEIN ISOLATION IN PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION. PACING CLIN ELECTROPHYSIOL. 2022 AUG 8. DOI: 10.1111/PACE.14578. EPUB AHEAD OF PRINT. PMID: 35939332. 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 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 REF #: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITATION HAS BEEN REVIEWED: JIANG R, CHEN M, FAN J, YI F, TANG A, LIU X, ZHU W, LIU S, HUANG X, LIU Q, JU W, ZHANG X, LI J, HE J, SHI L, ZHOU G, WANG Y, FU G, JIANG C. EFFICACY OF ABLATION INDEX-GUIDED PULMONARY VEIN ISOLATION IN PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION. PACING CLIN ELECTROPHYSIOL. 2022 AUG 8. DOI: 10.1111/PACE.14578. EPUB AHEAD OF PRINT. PMID: 35939332. OBJECTIVE/METHODS/STUDY DATA: AUTHORS AIMED TO EVALUATE WHETHER AI-GUIDED PVI IMPROVES CLINICAL OUTCOMES COMPARED TO CF-GUIDED PVI IN PATIENTS WITH PAROXYSMAL AF (PAF).PAF-AI TRIAL WAS A PROSPECTIVE, MULTI-CENTER, RANDOMIZED, CONTROLLED TRIAL COMPARING AI-GUIDED PVI AND CF-GUIDED PVI FOR PAROXYSMAL AF. THE TRIAL DESIGN HAS BEEN PUBLISHED PREVIOUSLY. PATIENTS WERE RECRUITED FROM NINE CENTERS IN CHINA. PATIENTS WERE ELIGIBLE IF THEY WERE 18-75 YEARS OLD, HAD SYMPTOMATIC PAROXYSMAL AF, HAD AT LEAST ONE ECG DOCUMENTED AF WITHIN 6 MONTHS. PATIENTS WITH MYOCARDIAL INFARCTION/CORONARY ARTERY BYPASS GRAFTING/PERCUTANEOUS CORONARY INTERVENTION WITHIN 3 MONTHS, LA DIAMETER >50 MM, LEFT VENTRICULAR EJECTION FRACTION (LVEF) <40%, NYHA III¿IV STATUS, PREVIOUS AF ABLATION, INTRACARDIAC THROMBUS, CONTRADICTIONS TO ANTICOAGULATION, AND FEMALES WHO ARE PREGNANT OR LACTATING ARE EXCLUDED FROM ENROLLMENT. PATIENTS WERE CENTRALLY RANDOMIZED IN A 2:1 RATIO TO TWO GROUPS: AI GUIDED PVI AND CF-GUIDED PVI. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SMARTTOUCH¿, OR SMARTTOUCH¿ SF, BIOSENSE WEBSTER, (B)(4), USA). OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO, BIOSENSE WEBSTER, LASSO OR PENTARAY, BIOSENSE WEBSTER, NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. ADVERSE EVENT(S) AND PROVIDED. INTERVENTIONS: QTY 2- CARDIAC TAMPONADE (IN AI GROUP) WAS OBSERVED AND WAS MANAGED CONSERVATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2346229 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening CARTO| LASSO OR PENTARAY