BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 18137005 · Received November 14, 2023

    Report

    Report Number
    2029046-2023-02638
    Event Type
    Injury
    Date Received
    November 14, 2023
    Date of Event
    October 19, 2023
    Report Date
    January 30, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009781
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. INVESTIGATION IS IN PROGRESS, ONCE COMPLETED A SUPPLEMENTAL WILL BE SUBMITTED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. 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

    ADDITIONAL INFORMATION WAS RECEIVED FOR THE ADVERSE EVENT OF CARDIAC TAMPONADE ON (B)(6) 2024. THE OUTCOME IS RECOVERED/RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED FOR THE ADVERSE EVENT OF BRADYCARDIA ON (B)(6) 2024. THE DISCHARGE DATE WAS (B)(6) 2023. THE OUTCOME IS RECOVERED/RESOLVED. 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 WAS RECEIVED FOR THE ADVERSE EVENT OF CARDIAC TAMPONADE ON (B)(6) 2023. THE DISCHARGE DATE WAS (B)(6) 2023. ADDITIONAL INFORMATION WAS RECEIVED FOR THE ADVERSE EVENT OF CARDIAC TAMPONADE ON (B)(6) 2023. THE CARDIAC TAMPONADE WAS CATEGORIZED AS SEVERE. RELATIONSHIP TO STUDY DEVICES IS CAUSAL RELATIONSHIP TO BOTH THE THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER. SINCE THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER RELATIONSHIP TO STUDY DEVICE FOR THE CARDIAC TAMPONADE ADVERSE EVENT IS UPDATED TO CASUAL, THIS ADVERSE EVENT IS NOW ALSO ASSESSED AS MDR REPORTABLE UNDER THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER. THE AWARENESS DATE FOR THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER REPORT IS (B)(6) 2023. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO REPORTS: (1) MFR # 2029046-2023-02638 FOR PRODUCT CODE D134702 (THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER). (2) MFR # 2029046-2023-03032 FOR PRODUCT CODE D128208 (PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER) THE INVESTIGATION WAS COMPLETED ON (B)(6) 2023. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31122872L NUMBER, AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. 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

    DURING A CLINICAL TRIAL, IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE AND BRADYCARDIA, WHICH REQUIRED MEDICATION, PACEMAKER IMPLANTATION AND PROLONGED HOSPITALIZATION. PATIENT RECEIVED A CARDIAC ABLATION ON (B)(6) 2023 (INDEX PROCEDURE) UNDER CONSCIOUS SEDATION. ON (B)(6) 2023, PATIENT EXPERIENCED, CARDIAC TAMPONADE, CATEGORIZED AS MODERATE SEVERITY. THIS IS CONSIDERED A SERIOUS EVENT DUE TO SERIOUS DETERIORATION IN THE HEALTH OF THE SUBJECT AS DEFINED BY A LIFE THREATENING ILLNESS / INJURY AND PROLONGED HOSPITALIZATION (ADMISSION DATE (B)(6) 2023). RELATIONSHIP TO STUDY DEVICE IS NOT RELATED AND RELATIONSHIP TO PRIMARY STUDY PROCEDURE IS CAUSAL RELATIONSHIP TO THE INDEX PROCEDURE. THE ADVERSE EVENT IS EXPECTED/ANTICIPATED. THE OUTCOME IS NOT RECOVERED/NOT RESOLVED. INTERVENTION WAS MEDICATION. ON (B)(6) 2023, PATIENT EXPERIENCED AE#2, BRADYCARDIA, CATEGORIZED AS MODERATE SEVERITY. THIS IS CONSIDERED A SERIOUS EVENT DUE TO SERIOUS DETERIORATION IN THE HEALTH OF THE SUBJECT AS DEFINED BY PROLONGED HOSPITALIZATION (ADMISSION DATE (B)(6) 2023). RELATIONSHIP TO STUDY DEVICE IS NOT RELATED AND RELATIONSHIP TO PRIMARY STUDY PROCEDURE IS CAUSAL RELATIONSHIP TO THE INDEX PROCEDURE. THE ADVERSE EVENT IS EXPECTED/ANTICIPATED. THE OUTCOME IS NOT RECOVERED/NOT RESOLVED. INTERVENTION WAS SURGERY (PACEMAKER IMPLANTATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906899 THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31122872L 10846835009781

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention| L| H NGEN RF GENERATOR.| PENTARAY NAV ECO 7FR, F, 2-6-2.| UNK_CARTO 3.