BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH UNIDIRECTIONAL

    MDR report key: 22309466 · Received June 23, 2025

    Report

    Report Number
    2029046-2025-02049
    Event Type
    Injury
    Date Received
    June 23, 2025
    Date of Event
    April 17, 2025
    Report Date
    June 23, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KAJDIC N, KALIN¿EK TP, ANTOLIC B, ¿I¿EK D, ¿TUBLAR J, DEM¿AR J, KUHELJ D, JAN M. IMPACT OF HIGH-DENSITY MAPPING ON PULMONARY VEIN ISOLATION DURABILITY: A RANDOMIZED, SINGLE-CENTER STUDY. PACING CLIN ELECTROPHYSIOL. 2025 MAY 6. DOI: 10.1111/PACE.15196. EPUB AHEAD OF PRINT. PMID: 40326295. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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. NOTE: FOR FIELD D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. 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: KAJDIC N, KALIN¿EK TP, ANTOLIC B, ¿I¿EK D, ¿TUBLAR J, DEM¿AR J, KUHELJ D, JAN M. IMPACT OF HIGH-DENSITY MAPPING ON PULMONARY VEIN ISOLATION DURABILITY: A RANDOMIZED, SINGLE-CENTER STUDY. PACING CLIN ELECTROPHYSIOL. 2025 MAY 6. DOI: 10.1111/PACE.15196. EPUB AHEAD OF PRINT. PMID: 40326295. BACKGROUND: DESPITE TECHNICAL PROGRESS AND NOVEL ABLATION STRATEGIES, PULMONARY VEIN (PV) RECONNECTION STILL OCCURS IN A SUBSTANTIAL PROPORTION OF PATIENTS. THE AIM OF THE STUDY WAS TO DETERMINE THE IMPACT OF THE ELIMINATION OF ANTRAL LOW-VOLTAGE, FRAGMENTED ELECTROGRAMS (LFEGMS) IDENTIFIED BY HIGH-DENSITY (HD) MAPPING ON THE RATE OF PULMONARY VEIN ISOLATION (PVI) DURABILITY. OBJECTIVE: THE AIM OF THE STUDY WAS TO DETERMINE THE IMPACT OF THE ELIMINATION OF ANTRAL LFEGMS IDENTIFIED BY HD MAPPING ON THE RATE OF PVI DURABILITY. METHODS: SIXTY PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION (PAF) WERE RANDOMLY ASSIGNED TO A VERIFICATION OF PV ENTRANCE BLOCK AND PRESENCE OF LFEGMS ON ANTRAL ISOLATION LINES WITH AN HD MAPPING CATHETER (HD GROUP) OR TO A VERIFICATION OF PV ENTRANCE BLOCK WITH A CIRCUMFERENTIALMAPPING CATHETER ALONE (CMGROUP). IN THEHDGROUP, LFEGMSWERE ADDITIONALLY ABLATED. MANDATORY REASSESSMENT PROCEDURE TO ASSESS PVI DURABILITY AND THE PRESENCE OF LFEGMS WAS PERFORMED 12 MONTHS AFTER THE INDEX PROCEDURE OR EARLIER IN CASE OF ARRHYTHMIA RECURRENCE. CONCLUSIONS: ADDITIONAL ELIMINATION OF LFEGMS IDENTIFIED BY HD MAPPING OF ANTRAL ISOLATION LINES AFTER PVI RESULTED IN A SIGNIFICANTLY HIGHER RATE OF PVI DURABILITY. OUR FINDINGS WARRANT FURTHER ADEQUATELY POWERED CLINICAL TRIALS TO ADDRESS THE IMPACT OF THE ELIMINATIONOF LFEGMS IN ANTRAL ISOLATION LINES ON THE RATE OF ARRHYTHMIA RECURRENCE. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: ABLATION CATHETER (THERMOCOOL SMARTTOUCH CATHETER, D OR F CURVE, BIOSENSE WEBSTER, CA, USA). OTHER BWI PRODUCTS: (CARTO 3 SYSTEM), LASSO NAV ECO CATHETER OR LASSO CIRCULAR MAPPING CATHETER, MAPPING CATHETER (PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER). NON-BWI DEVICES: ELECTRO-ANATOMICAL MAPPING (EAM) SYSTEM. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICES: QTY 1: 1 PATIENT HAD CARDIAC TAMPONADE. TREATMENT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926860 UNK_SMART TOUCH UNIDIRECTIONAL CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening