BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 25186690 · Received May 15, 2026

    Report

    Report Number
    2029046-2026-01584
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    March 3, 2026
    Report Date
    May 15, 2026
    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

    D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE ARTICLE HAS BEEN REVIEWED: DING P, CHEN W, SHEN J, QIU B, HU X, XIE L, LIU Z, LI F, GE L, WEI H, ZHANG B, ZHANG Q, WANG Z, CHEN M, LI C, ZHANG C. INCIDENCE OF SILENT CEREBRAL LESIONS DURING PULSED FIELD ABLATION FOR PAROXYSMAL ATRIAL FIBRILLATION. ANN MED. 2026 DEC;58(1):2634472. DOI: 10.1080/07853890.2026.2634472. EPUB 2026 MAR 3. PMID: 41774050; PMCID: PMC12958377. 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 ARTICLE HAS BEEN REVIEWED: DING P, CHEN W, SHEN J, QIU B, HU X, XIE L, LIU Z, LI F, GE L, WEI H, ZHANG B, ZHANG Q, WANG Z, CHEN M, LI C, ZHANG C. INCIDENCE OF SILENT CEREBRAL LESIONS DURING PULSED FIELD ABLATION FOR PAROXYSMAL ATRIAL FIBRILLATION. ANN MED. 2026 DEC;58(1):2634472. DOI: 10.1080/07853890.2026.2634472. EPUB 2026 MAR 3. PMID: 41774050; PMCID: PMC12958377. BACKGROUND: RADIOFREQUENCY CATHETER ABLATION (RFCA) IS A FIRST-LINE TREATMENT FOR PAROXYSMAL ATRIAL FIBRILLATION (PAF). COMPLICATIONS SUCH AS SILENT CEREBRAL LESION (SCL) MAY OCCUR DURING ABLATION. PULSED FIELD ABLATION (PFA) IS A NON-THERMAL METHOD THATABLATES CARDIAC TISSUE VIA IRREVERSIBLE ELECTROPORATION. LIMITED STUDIES HAVE REPORTED THE INCIDENCE OF SCL DURING PFA, WITH HIGHLY VARIABLE RESULTS. HOWEVER, RANDOMIZED CONTROLLED TRIALS (RCTS) REMAIN SCARCE. THE OBJECTIVE OF THIS STUDY WAS TO COMPARE PERIOPERATIVE SCL INCIDENCE BETWEEN PFA AND RFCA, AND TO IDENTIFY RISK FACTORS FOR SCL DURING PFA. OBJECTIVES: TO COMPARE THE INCIDENCE OF PERIOPERATIVE SILENT CEREBRAL LESIONS (SCL) BETWEEN PULSED FIELD ABLATION (PFA) AND RADIOFREQUENCY CATHETER ABLATION (RFCA), AND TO IDENTIFY RISK FACTORS FOR SCL DURING PFA. METHODS: IN THIS PROSPECTIVE PILOT RCT (CHICTR2400088774), 62 PATIENTS WITH PAF WERE RANDOMIZED 1:1 TO UNDERGO PFA OR RFCA. CEREBRAL MRI (3.0 T) WAS PERFORMED PREOPERATIVELY AND 24¿48H POSTOPERATIVELY. SCL WAS DEFINED AS A NEW ACUTE BRAIN LESION ON MRI WITHOUT NEUROLOGICAL DEFICITS. BASELINE AND SURGICAL DATA OF THE PATIENTS WERE COLLECTED. CONCLUSION: SCL INCIDENCE WAS 12.90% IN THE PFA GROUP VERSUS 6.45% IN THE RFCA GROUP. WHILE NO STATISTICALLY SIGNIFICANT DIFFERENCE WAS DETECTED BETWEEN TWO GROUPS, THE NUMERICALLY HIGHER RATE IN THE PFA GROUP WARRANTS LARGER STUDIES TO EVALUATE CEREBRAL SAFETY ASSOCIATED WITH PFA. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: IRRIGATED-TIP ABLATION CATHETER (STSF, BIOSENSE WEBSTER) OTHER BWI PRODUCTS: PFA GROUP: INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER (SOUNDSTAR 10 FR, BIOSENSE WEBSTER). RFCA GROUP: ICE CATHETER (SOUNDSTAR 10 F, BIOSENSE WEBSTER), ELECTROANATOMIC MAPPING SYSTEM (CARTO 3, BIOSENSE WEBSTER). NON-BWI DEVICES: PFA GROUP: STEERABLE DECA-POLAR CATHETER, 8.5-FR SWARTZ SL1 SHEATH, 8 F DISPOSABLE CARDIAC PFA CATH ETER FEATURES A 5.5-FR DISTAL TIP (8-FR PROXIMAL SHAFT), LEAD-MAPPING 3D ELECTROANATOMIC SYSTEM (SICHUAN JINJIANG ELECTRONIC TECHNOLOGY CO., LTD.). RFCA GROUP: 8.5 FR SWARTZ SL1 SHEATH, STEERABLE DECA-POLAR CATHETER, 11 F SHEATH. THE 4 CASES OF SILENT CEREBRAL LESION (SCL) WAS OBSERVED IN THE PFA GROUP MIGHT BE ASSOCIATED WITH THE USE OF THE CIRCULAR PFA CATHETER (JINJIANG ELECTRONIC). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICES: UNK_SMART TOUCH UNIDIRECTIONAL SF. QTY 2: 2 PATIENTS DEVELOPED SILENT CEREBRAL LESION (SCL). NO INTERVENTION MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334087 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening