BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART TOUCH BIDIRECTIONAL SF

    MDR report key: 24865404 · Received April 13, 2026

    Report

    Report Number
    2029046-2026-01196
    Event Type
    Injury
    Date Received
    April 13, 2026
    Date of Event
    February 11, 2026
    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

    MANUFACTURER'S REF. NO: (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: SCIACCA V, HATAHET S, HEEGER CH, MAMAEV R, PAJAZITI E, NGHIEM L, SCHULTEN-BAUMER J, TRAUB A, REINCKE S, KIRSTEIN B, TRAJANOSKI D, PHAN HL, GROSSE N, LOPEZ LD, VOGLER J, MAKIMOTO H, EITEL C, KUCK KH, FINK T, TILZ RR. EVALUATION OF ABLATION INDEX-GUIDED LINEAR LESIONS FORMATION FOR LEFT ATRIAL ARRHYTHMIA TREATMENT. J INTERV CARD ELECTROPHYSIOL. 2026 FEB 11. DOI: 10.1007/S10840-025-02232-3. EPUB AHEAD OF PRINT. PMID: 41670875. 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: FELD D4. CATALOG SHOULD BE "UNK_SMART TOUCH BIDIRECTIONAL 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. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: SCIACCA V, HATAHET S, HEEGER CH, MAMAEV R, PAJAZITI E, NGHIEM L, SCHULTEN-BAUMER J, TRAUB A, REINCKE S, KIRSTEIN B, TRAJANOSKI D, PHAN HL, GROSSE N, LOPEZ LD, VOGLER J, MAKIMOTO H, EITEL C, KUCK KH, FINK T, TILZ RR. EVALUATION OF ABLATION INDEX-GUIDED LINEAR LESIONS FORMATION FOR LEFT ATRIAL ARRHYTHMIA TREATMENT. J INTERV CARD ELECTROPHYSIOL. 2026 FEB 11. DOI: 10.1007/S10840-025-02232-3. EPUB AHEAD OF PRINT. PMID: 41670875. BACKGROUND: CATHETER BASED LEFT ATRIAL LINEAR LESION ABLATION IS COMMONLY PERFORMED IN PATIENTS WITH ATRIAL FIBRILLATION (AF) AND COMPLEX LEFT ATRIAL SUBSTRATE OR IN PATIENTS PRESENTING WITH MACRO-REENTRANT LEFT ATRIAL TACHYCARDIA (LAT). OBJECTIVE: TO ASSESS ACUTE AND LONG-TERM EFFECTIVENESS, PROCEDURAL VIABILITY AND SAFETY OF ABLATION INDEX (AI)-GUIDED COMPARED TO CONTACT FORCE (CF)-GUIDED ABLATION OF LEFT ATRIAL LINEAR LESIONS. METHODS: CONSECUTIVE PATIENTS UNDERGOING LEFT ATRIAL ABLATION FOR AF OR LAT INCLUDING LEFT ATRIAL LINEAR LESIONS ABLATION EITHER GUIDED BY AI OR CF WITHOUT AI WERE PROSPECTIVELY ENROLLED. CHARACTERISTICS OF ANTERIOR LINES (AL), MITRAL ISTHMUS LINES (MIL), ROOF LINES (RFL) AND POSTERIOR WALL ISOLATION (PWI) WERE SYSTEMATICALLY ANALYZED IN BOTH COHORTS. PROCEDURAL FEASIBILITY, SAFETY, ACUTE AND LONG-TERM BLOCK OF LINEAR LESIONS AS WELL AS CLINICAL OUTCOME IN TERMS OF ARRHYTHMIA RECURRENCE WERE ASSESSED. CONCLUSIONS: AI-GUIDED ABLATION IS ASSOCIATED WITH SIGNIFICANTLY HIGHER RATES OF ACUTE CONDUCTION BLOCK ACROSS MIL, SHORTER RF TIMES AND LOWER FTI FOR AL AND RFL WHILE COMPLICATION RATES AND LONG-TERM CLINICAL OUTCOME ARE COMPARABLE TO NON AI-GUIDED ABLATION. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: USING A CONTACT FORCE ENABLING OPEN-IRRIGATED TIP CATHETER (THERMOCOOL SMART-TOUCH SF D OR F CURVE, BIOSENSE WEBSTER, DIAMOND BAR, CA, USA) OTHER BWI PRODUCTS: SPIRAL MAPPING CATHETER (LASSO, BIOSENSE WEBSTER) NON-BWI DEVICES: 8.5 F TRANSSEPTAL SHEATHS AND A PUNCTURE NEEDLE (SL1 SHEATH AND BRK-1 TSP NEEDLE, ST. JUDE MEDICAL, INC., ST. PAUL, MN, USA) ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICES: QTY 2: 2 PATIENT HAD CARDIAC TAMPONADE IN AI-GUIDED ABLATION GROUP. QTY 1: 1 PATIENT HAD PHRENIC NERVE PALSY IN AI-GUIDED ABLATION GROUP. NO INTERVENTION MENTIONED. QTY 2: 2 PATIENT HAD STROKE /TIA IN AI-GUIDED ABLATION GROUP. NO INTERVENTION MENTIONED. QTY 3: 3 PATIENT HAD PERMANENT PACEMAKER IMPLANTATION IN AI-GUIDED ABLATION GROUP. NO INTERVENTION MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915100 SMART TOUCH BIDIRECTIONAL SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R