BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART TOUCH UNIDIRECTIONAL SF

    MDR report key: 22301771 · Received June 20, 2025

    Report

    Report Number
    2029046-2025-02032
    Event Type
    Injury
    Date Received
    June 20, 2025
    Date of Event
    January 24, 2025
    Report Date
    June 20, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: LENGAUER S, ERHARD N, POPA MA, TELISHEVSKA M, KRAFFT H, BAHLKE F, ENGLERT F, BOURIER F, REENTS T, DEISENHOFER I, HESSLING G. VERY HIGH-POWER SHORT-DURATION ABLATION FOR ATRIAL FIBRILLATION IN ADULTS WITH CONGENITAL HEART DISEASE. J CARDIOVASC ELECTROPHYSIOL. 2025 MAR;36(3):625-631. DOI: 10.1111/JCE.16567. EPUB 2025 JAN 24. PMID: 39853802; PMCID: PMC11903373. 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. NOTE: FOR FIELD D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. NOTE: FIELD D4. CATALOG SHOULD BE UNK_SMART TOUCH UNIDIRECTIONAL SF. 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. 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: LENGAUER S, ERHARD N, POPA MA, TELISHEVSKA M, KRAFFT H, BAHLKE F, ENGLERT F, BOURIER F, REENTS T, DEISENHOFER I, HESSLING G. VERY HIGH-POWER SHORT-DURATION ABLATION FOR ATRIAL FIBRILLATION IN ADULTS WITH CONGENITAL HEART DISEASE. J CARDIOVASC ELECTROPHYSIOL. 2025 MAR;36(3):625-631. DOI: 10.1111/JCE.16567. EPUB 2025 JAN 24. PMID: 39853802; PMCID: PMC11903373. BACKGROUND: DATA REGARDING SAFETY AND LONG-TERM OUTCOME OF VERY HIGH-POWER-SHORT DURATION (VHPSD) ABLATION IN ADULT CONGENITAL HEART DISEASE (ACHD) PATIENTS WITH PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION (AF) ARE LACKING. OBJECTIVE: AS DATA USING VHPSD IN ACHD PATIENTS UNDERGOING AF ABLATION ARE LACKING, WE ANALYZED THE SAFETY AND EFFICACY OF THIS NEW TECHNIQUE. METHODS: RETROSPECTIVE OBSERVATIONAL SINGLE-CENTER STUDY. THE DATA OF 66 CONSECUTIVE ACHD PATIENTS (MEAN AGE 60 ± 12.8 YEARS, 46% MALE) WITH MILD (69.7%), MODERATE (22.7%), OR COMPLEX (7.6%) CONGENITAL HEART DISEASE (CHD) WHO UNDERWENT ABLATION FOR PAROXYSMAL (40.9%) OR PERSISTENT AF (59.1%) WERE ANALYZED. CIRCUMFERENTIAL PVI WAS PERFORMED IN ALL PATIENTS AND ADDITIONAL SUBSTRATE ABLATION IN 79,4% OF PERSISTENT AF PATIENTS USING IRRIGATED RF ENERGY WITH VHPSD SETTINGS OF 70 W/5¿7 S OR 60 W/7¿10 S. CONCLUSIONS: VHPSD FOR ABLATION OF PAROXYSMAL OR PERSISTENT AF IN ACHD PATIENTS IS SAFE AND EFFECTIVE. REGARDLESS OF CHD COMPLEXITY, NO VHPSD ABLATION MODALITY RELATED COMPLICATIONS OCCURRED. LONG-TERM OUTCOME FOR PAROXYSMAL AF AFTER ONE ABLATION WAS EXCELLENT WHEREAS RESULTS FOR PERSISTENT AF WERE LIMITED. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: 3.5MM IRRIGATED-TIP CATHETER THERMOCOOL SMARTTOUCH SF/SMARTABLATE RF GENERATOR (BIOSENSE WEBSTER). OTHER BWI PRODUCTS: CARTO 3 (BIOSENSE WEBSTER). NON-BWI DEVICES: ENSITE PRECISION OR ENSITE X (ABBOTT), FLEXIBILITY SE/AMPERE RF GENERATOR (ABBOTT), STEERABLE 11.7-FR SHEATH (AGILISTM; ABBOTT). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICES: QTY 3: 3 PATIENTS HAD PSEUDOANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1670111 SMART TOUCH UNIDIRECTIONAL SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention CARTO 3 SYSTEM| ENSITE PRECISION| ENSITE X (ABBOTT)| FLEXIBILITY SE/AMPERE RF GENERATOR (ABBOTT)| STEERABLE 11.7-FR SHEATH (AGILISTM, ABBOTT)