BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH UNIDIRECTIONAL

    MDR report key: 23654458 · Received November 26, 2025

    Report

    Report Number
    2029046-2025-03939
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    October 8, 2025
    Report Date
    November 26, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: HU X, JIANG W, WANG X, YE P, LI X, WANG Y, ZHENG Q, WANG Y, LENG L, ZHANG Z, HAN B, ZHANG Y, QIN M, LIU X, HOU X; ICE VS TEE STUDY INVESTIGATORS. INTRACARDIAC VS TRANSESOPHAGEAL ECHOCARDIOGRAPHY IN ATRIAL FIBRILLATION ABLATION: A RANDOMIZED CLINICAL TRIAL. JAMA CARDIOL. 2025 OCT 8:E253687. DOI: 10.1001/JAMACARDIO.2025.3687. EPUB AHEAD OF PRINT. PMID: 41060665; PMCID: PMC12509080. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (B)(4) IS NOT AVAILABLE. 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 CITE HAS BEEN REVIEWED: HU X, JIANG W, WANG X, YE P, LI X, WANG Y, ZHENG Q, WANG Y, LENG L, ZHANG Z, HAN B, ZHANG Y, QIN M, LIU X, HOU X; ICE VS TEE STUDY INVESTIGATORS. INTRACARDIAC VS TRANSESOPHAGEAL ECHOCARDIOGRAPHY IN ATRIAL FIBRILLATION ABLATION: A RANDOMIZED CLINICAL TRIAL. JAMA CARDIOL. 2025 OCT 8:E253687. DOI: 10.1001/JAMACARDIO.2025.3687. EPUB AHEAD OF PRINT. PMID: 41060665; PMCID: PMC12509080. BACKGROUND: TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IS THE STANDARD IMAGING MODALITY FOR THROMBUS SCREENING PRIOR TO ATRIAL FIBRILLATION (AF) ABLATION BUT CARRIES PROCEDURAL RISKS. INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IS AN ALTERNATIVE THAT MAY OFFER COMPARABLE SAFETY WITH PROCEDURAL ADVANTAGES. OBJECTIVE: TO DETERMINE WHETHER ICE IS NONINFERIOR TO TEE IN PREVENTING PERIPROCEDURAL THROMBOEMBOLIC EVENTS IN AF ABLATION. METHODS: THIS MULTICENTER RANDOMIZED CLINICAL TRIAL WAS CONDUCTED AT 10 HOSPITALS IN CHINA FROM AUGUST 2022 TO JULY 2023, WITH A 30-DAY FOLLOW-UP, ENROLLING ADULTS WITH AF SCHEDULED FOR CATHETER ABLATION WHO MET PREDEFINED ELIGIBILITY CRITERIA. DATA ANALYSIS WAS PERFORMED FROM AUGUST 2023 TO DECEMBER 2023. CONCLUSIONS: IN THIS MULTICENTER RANDOMIZED CLINICAL TRIAL, ICE WAS NONINFERIOR TO TEE FOR PREVENTING THROMBOEMBOLIC COMPLICATIONS IN AF ABLATION AND OFFERED ADDITIONAL ADVANTAGES IN SAFETY, EFFICIENCY, AND PATIENT COMFORT, SUPPORTING ITS USE AS A VIABLE ALTERNATIVE IN CLINICAL PRACTICE. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: 3.5-MM IRRIGATED OPEN-TIP CATHETER (THERMOCOOL SMARTTOUCH CATHETER D-F CURVE [BIOSENSE WEBSTER]). OTHER BWI PRODUCTS: CARTO 3 NAVIGATION SYSTEM AND A 10F SOUNDSTAR CATHETER (BIOSENSE WEBSTER). NON-BWI DEVICES: FLUOROSCOPY (UNKNOWN MANUFACTURER), TRANSSEPTAL SHEATHS (UNKNOWN MANUFACTURER) AND 11F SHEATH (UNKNOWN MANUFACTURER). 1 CASE OF STROKE AND 3 CASES OF TRANSIENT ISCHEMIC ATTACK (TIA) IN THE ICE GROUP AND 5 CASES IN THE TEE GROUP WILL NOT BE CAPTURED AS THIS WAS REPORTED TO BE CAUSED BY VASCULAR PUNCTURE RELATED TO UNKNOWN SHEATHS. 2 CASES OF MAJOR BLEEDING RELATED WITH TRANSSEPTAL PUNCTURE IN THE ICE GROUP AND 11 CASES IN THE TEE GROUP WILL NOT BE CAPTURED SINCE THESE EVENTS WERE RELATED TO TRANSSEPTAL MOST LIKELY WITH THE USE OF SHEATHS WHERE IN NO MENTIONED OF BWI SHEATH DEVICES. 8 CASES OF GROIN HEMATOMA IN THE ICE GROUP AND 7 CASES IN THE TEE GROUP WILL NOT BE CAPTURED SINCE THESE EVENTS WERE MOST LIKELY RELATED TO SHEATH DEVICES WHERE IN NO MENTIONED OF BWI SHEATH DEVICES. 2 CASES OF PSEUDOANEURYSM IN THE ICE GROUP AND 3 CASES IN THE TEE GROUP WILL NOT BE CAPTURED SINCE THESE EVENTS WERE MOST LIKELY RELATED TO SHEATH DEVICES WHERE IN NO MENTIONED OF BWI SHEATH DEVICES. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR UNK_SMART TOUCH UNIDIRECTIONAL: QTY 13: 13 PATIENTS HAD PRESENCE OF THROMBUS OR DETECTED WITH IN THE (LAA), LEFT ATRIAL APPENDAGE IN THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) GROUP. NO INTERVENTION MENTIONED. QTY 5: 5 PATIENTS HAD PRESENCE OF THROMBUS OR DETECTED OUTSIDE THE (LAA), LEFT ATRIAL APPENDAGE IN THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) GROUP. NO INTERVENTION MENTIONED. QTY 14: 14 PATIENTS HAD PRESENCE OF THROMBUS OR DETECTED WITH IN THE (LAA), LEFT ATRIAL APPENDAGE IN THE TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) GROUP. NO INTERVENTION MENTIONED. QTY 5: 5 PATIENTS HAD PERICARDIAL EFFUSIONS (PROCEDURE-RELATED COMPLICATIONS) IN THE ICE GROUP. NO INTERVENTION MENTIONED. QTY 7: 7 PATIENTS HAD PERICARDIAL EFFUSIONS (PROCEDURE-RELATED COMPLICATIONS) IN THE TEE GROUP. NO INTERVENTION MENTIONED. QTY 2: 2 PATIENTS HAD CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS OR SURGERY (PROCEDURE-RELATED COMPLICATIONS) IN THE ICE GROUP. QTY 9: 9 PATIENTS HAD CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS OR SURGERY (PROCEDURE-RELATED COMPLICATIONS) IN THE TEE GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946457 UNK_SMART TOUCH UNIDIRECTIONAL CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R 10F SOUNDSTAR CATHETER| 11F SHEATH (UNKNOWN MANUFACTURER)| CARTO 3 SYSTEM| FLUOROSCOPY (UNKNOWN MANUFACTURER)| TRANSSEPTAL SHEATHS (UNKNOWN MANUFACTURER)| UNK_SMART TOUCH UNIDIRECTIONAL