BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH BIDIRECTIONAL

    MDR report key: 18935522 · Received March 19, 2024

    Report

    Report Number
    2029046-2024-00917
    Event Type
    Injury
    Date Received
    March 19, 2024
    Date of Event
    February 28, 2024
    Report Date
    March 19, 2024
    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 CITE HAS BEEN REVIEWED: ZENG L, CHEN S, ZENG R, HU H, YANG Q, CUI K, CHEN Q, FU H, PU X. CLOSE PROTOCOL VERSUS LOWER ABLATION INDEX VALUE FOR PAROXYSMAL ATRIAL FIBRILLATION: A RANDOMIZED NONINFERIOR CLINICAL TRIAL. J CARDIOVASC ELECTROPHYSIOL. 2024 MAR;35(3):469-477. DOI: 10.1111/JCE.16194. EPUB 2024 JAN 28. PMID: 38282257. 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: ZENG L, CHEN S, ZENG R, HU H, YANG Q, CUI K, CHEN Q, FU H, PU X. CLOSE PROTOCOL VERSUS LOWER ABLATION INDEX VALUE FOR PAROXYSMAL ATRIAL FIBRILLATION: A RANDOMIZED NONINFERIOR CLINICAL TRIAL. J CARDIOVASC ELECTROPHYSIOL. 2024 MAR;35(3):469-477. DOI: 10.1111/JCE.16194. EPUB 2024 JAN 28. PMID: 38282257. OBJECTIVE/METHODS/STUDY DATA: INTRODUCTION: THE OPTIMIZED ABLATION INDEX (AI) VALUE FOR CATHETER ABLATION OF ATRIAL FIBRILLATION (AF) REMAINS TO BE DEFINED. WE AIMED TO COMPARE THE EFFICACY AND SAFETY OF CLOSE PROTOCOL AND LOWER AI PROTOCOL IN PAROXYSMAL AF. METHODS AND RESULTS: PATIENTS WITH SYMPTOMATIC, DRUG-RESISTANT PAROXYSMAL AF FOR FIRST ABLATION WERE PROSPECTIVELY ENROLLED FROM SEPTEMBER 2020 TO JANUARY 2022. THE PATIENTS WERE RANDOMLY DIVIDED INTO CLOSE GROUP (AI = 550 FOR ANTERIOR/ROOF SEGMENTS AND =400 FOR POSTERIOR/INFERIOR SEGMENTS) AND LOWER AI GROUP (AI = 450 FOR ANTERIOR/ROOF SEGMENTS AND =350 FOR POSTERIOR/INFERIOR SEGMENTS). FIRST-PASS ISOLATION, ACUTE PULMONARY VEIN (PV) RECONNECTIONS, 1-YEAR ARRHYTHMIA RECURRENCE, AND MAJOR COMPLICATIONS WERE ASSESSED. OF THE 270 ENROLLED PATIENTS, 238 COMPLETED 1-YEAR FOLLOW-UP (118 IN CLOSE GROUP AND 120 IN LOWER AI GROUP). FIRST-PASS ISOLATION IN LEFT PVS WAS HIGHER IN CLOSE GROUP (71.2% VS. 53.3%, P = .005). ACUTE PV RECONNECTIONS WERE COMPARABLE BETWEEN GROUPS (9.3% VS. 14.2%, P = .246). AT 1 YEAR, 86.4% IN CLOSE GROUP VERSUS 81.7% IN LOWER AI GROUP WERE FREE FROM ATRIAL ARRHYTHMIA (LOG RANK P = .334). THE PROPORTION DIFFERENCE WAS -4.8% (95% CI: -14.1% TO 4.6%), AND P = .475 FOR NONINFERIORITY. STROKE OCCURRED IN FOUR PATIENTS OF LOWER AI GROUP, AND NO CARDIAC TAMPONADE, ATRIOESOPHAGEAL FISTULA, MAJOR BLEEDING OR DEATH OCCURRED POST PROCEDURE. CONCLUSION: FOR PATIENTS WITH PAROXYSMAL AF AND TREATED BY AI-GUIDED PV ABLATION, LOWER AI IS NOT NONINFERIOR TO CLOSE PROTOCOL. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH ABLATION CATHETER CONCOMITANT BIOSENSE WEBSTER DEVICES THAT WERE USED IN THIS STUDY: VIZIGO SHEATH, MOBICATH SHEATH, LASSO MAPPING CATHETER, PENTARAY MAPPING CATHETER, CARTO MAPPING SYSTEM CONCOMITANT NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED THERMOCOOL SMARTTOUCH ABLATION CATHETER: QTY 6 (STEAM POP) QTY 4 STROKES (CEREBROVASCULAR ACCIDENT)(RECOGNIZED PROCEDURAL COMPLICATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755481 UNK_SMART TOUCH BIDIRECTIONAL CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening UNK_CARTO MAPPING SYSTEM| UNK_LASSO| UNK_MOBICATH SHEATH| UNK_PENTARAY| UNK_VIZIGO SHEATH