BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 23376120 · Received October 23, 2025

    Report

    Report Number
    2029046-2025-03546
    Event Type
    Injury
    Date Received
    October 23, 2025
    Date of Event
    September 25, 2025
    Report Date
    February 6, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A 1. PATIENT IDENTIFIER: EXTERNAL REFERENCE: (B)(6). AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER 31710178L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. 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. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION TO FOLLOW UP REPORT # (B)(4): PATIENT CODE OF PROLONGED HOSPITALIZATION (F08) WAS REMOVED FROM H 6. HEALTH EFFECT - IMPACT CODE AS IT WAS ADDED TO THE CLINICAL RECORD IN ERROR. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    AN UPDATE WAS RECEIVED ON 07-OCT-2025. ADVERSE EVENT TERM VALUE OF "HYPOTENSION REQUIRING THERAPY DURING WAKE-UP PHASE AFTER VT-ABLATION" HAS BEEN CHANGED TO "HYPOTENSION DURING WAKE-UP PHASE AFTER VT-ABLATION" IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION INDICATED THAT PROLONGED HOSPITALIZATION VALUE OF "NO" HAS BEEN CHANGED TO "YES". THEREFORE, H 6. HEALTH EFFECT - IMPACT CODE HAS BEEN UPDATED TO INCLUDE THE CODE OF HOSPITALIZATION OR PROLONGED HOSPITALIZATION (F08). AN UPDATE WAS RECEIVED ON 07-OCT-2025. ADVERSE EVENT TERM VALUE OF "HYPOTENSION REQUIRING THERAPY DURING WAKE-UP PHASE AFTER VT-ABLATION" HAS BEEN CHANGED TO "HYPOTENSION DURING WAKE-UP PHASE AFTER VT-ABLATION" IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION TO FOLLOW UP REPORT # 2 (B)(4): THE STATEMENT BELOW WAS INADVERTENTLY ADDED SINCE IT HAS ALREADY BEEN INCLUDED ON FOLLOW UP #1 (B)(4). ¿AN UPDATE WAS RECEIVED ON 07-OCT-2025. ADVERSE EVENT TERM VALUE OF "HYPOTENSION REQUIRING THERAPY DURING WAKE-UP PHASE AFTER VT-ABLATION" HAS BEEN CHANGED TO "HYPOTENSION DURING WAKE-UP PHASE AFTER VT-ABLATION" IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CLINICAL TRIAL, THE PATIENT EXPERIENCED HYPOTENSION WHICH REQUIRED THERAPY AND MEDICATION. THE PATIENT RECEIVED INDEX CARDIAC ABLATION ON (B)(6) 2025. THE PATIENT EXPERIENCED HYPOTENSION REQUIRING THERAPY DURING WAKE-UP PHASE AFTER VT-ABLATION WITH THERMOCOOL SMARTTOUCH SF CATHETER (AE# 1) CATEGORIZED AS MODERATE AND SERIOUS. A LIFE-THREATENING ILLNESS OR INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION REQUIRED. RELATIONSHIP TO STUDY DEVICE IS NOT RELATED AND RELATIONSHIP TO THE INDEX STUDY PROCEDURE IS CAUSAL. THE EVENT IS ¿EXPECTED/ANTICIPATED.¿ THE OUTCOME IS RECOVERED/RESOLVED WITH END DATE OF (B)(6) 2025. INTERVENTION WAS MEDICATION AKRIMOR AND OTHER SHOCK POSITION + I.V. VOLUME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595210 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31710178L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention