BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART TOUCH UNIDIRECTIONAL SF

    MDR report key: 22312725 · Received June 23, 2025

    Report

    Report Number
    2029046-2025-02060
    Event Type
    Injury
    Date Received
    June 23, 2025
    Date of Event
    November 10, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF. NO: (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: SANG C, LIU Q, LAI Y, XIA S, JIANG R, LI S, GUO Q, LI Q, GAO M, GUO X, HUANG L, LIU N, JIANG C, ZUO S, LIU X, LI M, GE W, SONG S, CHEN L, XIE S, ZOU J, CHEN K, LIU X, HU H, WANG X, ZHANG J, WANG Z, WANG C, HE L, JIANG C, TANG R, ZHOU N, WANG Y, LONG D, DU X, JIANG C, MACLE L, DONG J, MA C; PROMPT-AF INVESTIGATORS. PULMONARY VEIN ISOLATION WITH OPTIMIZED LINEAR ABLATION VS PULMONARY VEIN ISOLATION ALONE FOR PERSISTENT AF: THE PROMPT-AF RANDOMIZED CLINICAL TRIAL. JAMA. 2025 FEB 4;333(5):381-389. DOI: 10.1001/JAMA.2024.24438. PMID: 39556379; PMCID: PMC11574720. 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. 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 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. NOTE: FIELD D4. CATALOG SHOULD BE UNK_SMART TOUCH UNIDIRECTIONAL SF. NOTE: FOR FIELD D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: SANG C, LIU Q, LAI Y, XIA S, JIANG R, LI S, GUO Q, LI Q, GAO M, GUO X, HUANG L, LIU N, JIANG C, ZUO S, LIU X, LI M, GE W, SONG S, CHEN L, XIE S, ZOU J, CHEN K, LIU X, HU H, WANG X, ZHANG J, WANG Z, WANG C, HE L, JIANG C, TANG R, ZHOU N, WANG Y, LONG D, DU X, JIANG C, MACLE L, DONG J, MA C; PROMPT-AF INVESTIGATORS. PULMONARY VEIN ISOLATION WITH OPTIMIZED LINEAR ABLATION VS PULMONARY VEIN ISOLATION ALONE FOR PERSISTENT AF: THE PROMPT-AF RANDOMIZED CLINICAL TRIAL. JAMA. 2025 FEB 4;333(5):381-389. DOI: 10.1001/JAMA.2024.24438. PMID: 39556379; PMCID: PMC11574720. BACKGROUND AND PURPOSE: SUCCESS RATES OF PULMONARY VEIN ISOLATION (PVI) ARE MODEST FOR PERSISTENT ATRIAL FIBRILLATION (AF). ADDITIONAL LINEAR ABLATION BEYOND PVI HAS NOT BEEN PROVED SUPERIOR TO PVI ALONE IN RANDOMIZED TRIALS. ETHANOL INFUSION OF THE VEIN OF MARSHALL (EIVOM) FACILITATES ABLATION AT THE MITRAL ISTHMUS AND MAY LEAD TO IMPROVED EFFECTIVENESS OF A LINEAR ABLATION STRATEGY. THE PURPOSE OF THE STUDY IS TO DETERMINE WHETHER LINEAR ABLATION WITH RADIOFREQUENCY ENERGY COMBINED WITH ETHANOL INFUSION OF THE VEIN OF MARSHALL (EIVOM) ADDED TO PULMONARY VEIN ISOLATION (PVI) IMPROVES SINUS RHYTHM MAINTENANCE COMPARED WITH PVI ALONE IN PATIENTS WITH PERSISTENT ATRIAL FIBRILLATION (AF). BETWEEN AUGUST 27, 2021, TO JULY 16, 2023, A TOTAL OF 498 PATIENTS AGED 18 TO 80 YEARS, WITH AF PERSISTING FOR MORE THAN 3 MONTHS, UNDERGOING FIRST-TIME AF ABLATION, WERE ENROLLED AND RANDOMIZED. INTERVENTIONS: PATIENTS WERE RANDOMIZED TO UNDERGO PVI ALONE OR PVI PLUS EIVOM AND LINEAR ABLATION (INTERVENTION). THE LATTER GROUP FIRST UNDERWENT EIVOM, FOLLOWED BY PVI AND LINEAR ABLATION OF THE LEFT ATRIAL ROOF, MITRAL ISTHMUS, AND CAVOTRICUSPID ISTHMUS. CONCLUSION: AMONG PATIENTS WITH PERSISTENT AF, LINEAR ABLATION COMBINED WITH EIVOM IN ADDITION TO PVI SIGNIFICANTLY IMPROVED FREEDOM FROM ATRIAL ARRHYTHMIAS WITHIN 12 MONTHS COMPARED WITH PVI ALONE. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH SURROUND FLOW CATHETER. OTHER BWI DEVICE(S): CARTO 3 MAPPING SYSTEM. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK_SMART TOUCH UNIDIRECTIONAL SF: 7 PATIENTS ASSIGNED TO PULMONARY VEIN ISOLATION (PVI) PLUS LINEAR ABLATION EXPERIENCED PERICARDITIS OR PERICARDIAL EFFUSION NOT REQUIRING DRAINAGE, WHICH MAY RESULT IN ADDITIONAL MEDICAL THERAPY AND PROLONGED HOSPITALIZATION, COMPARED WITH NONE IN PVI GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1998736 SMART TOUCH UNIDIRECTIONAL SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization