BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 19620499 · Received June 26, 2024

    Report

    Report Number
    2029046-2024-02104
    Event Type
    Injury
    Date Received
    June 26, 2024
    Date of Event
    March 19, 2024
    Report Date
    June 26, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835008982
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KURATA M, BATNYAM U, TEDROW UB, RICHARDSON TD, KANAGASUNDRAM AN, HASEGAWA K, UETAKE S, MANUELIAN D, PELLEGRINI C, STEVENSON WG. INTRAMURAL NEEDLE ABLATION OR REPEATED STANDARD ABLATION IN PATIENTS REFERRED FOR REPEAT ABLATION OF SCAR-RELATED VENTRICULAR TACHYCARDIA. J CARDIOVASC ELECTROPHYSIOL. 2024 MAY;35(5):994-1004. DOI: 10.1111/JCE.16250. EPUB 2024 MAR 19. PMID: 38501333. 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 NO LOT NUMBER WAS 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. MANUFACTURER'S REF #: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KURATA M, BATNYAM U, TEDROW UB, RICHARDSON TD, KANAGASUNDRAM AN, HASEGAWA K, UETAKE S, MANUELIAN D, PELLEGRINI C, STEVENSON WG. INTRAMURAL NEEDLE ABLATION OR REPEATED STANDARD ABLATION IN PATIENTS REFERRED FOR REPEAT ABLATION OF SCAR-RELATED VENTRICULAR TACHYCARDIA. J CARDIOVASC ELECTROPHYSIOL. 2024 MAY;35(5):994-1004. DOI: 10.1111/JCE.16250. EPUB 2024 MAR 19. PMID: 38501333. OBJECTIVE/METHODS/STUDY DATA: INTRODUCTION: WHEN VENTRICULAR TACHYCARDIA (VT) RECURS AFTER STANDARD RF ABLATION (SRFA) SOME PATIENTS BENEFIT FROM REPEAT SRFA, WHEREAS OTHERS WARRANT ADVANCED METHODS SUCH AS INTRAMURAL NEEDLE ABLATION (INA). OUR OBJECTIVES ARE TO ASSESS THE UTILITY OF REPEAT SRFA AND TO CLARIFY THE BENEFIT OF INA WHEN REPEAT SRFA FAILS IN PATIENTS WITH VT DUE TO STRUCTURAL HEART DISEASE. METHODS: IN CONSECUTIVE PATIENTS WHO WERE PROSPECTIVELY ENROLLED IN A STUDY FOR INA FOR RECURRENT SUSTAINED MONOMORPHIC VT DESPITE SRFA, REPEAT SRFA WAS CONSIDERED FIRST. INA WAS PERFORMED DURING THE SAME PROCEDURE IF REPEAT SRFA FAILED OR NO TARGETS FOR SRFA WERE IDENTIFIED. RESULTS: OF 85 PATIENTS ENROLLED, ACUTE SUCCESS WITH REPEAT SRFA WAS ACHIEVED IN 30 PATIENTS (35%), AND DURING THE 6-MONTH FOLLOW-UP, 87% (20/23) WERE FREE OF VT HOSPITALIZATION, 78% WERE FREE OF ANY VT, AND 7 WERE LOST TO FOLLOW-UP. INA WAS PERFORMED IN 55 PATIENTS (65%) AFTER SRFA FAILED, OR NO ENDOCARDIAL TARGETS WERE FOUND ABOLISHED OR MODIFIED INDUCIBLE VT IN 35/55 PATIENTS (64%). DURING FOLLOW-UP, 72% (39/54) WERE FREE OF VT HOSPITALIZATION, 41% WERE FREE OF ANY VT, AND 1 WAS LOST TO FOLLOW-UP. OVERALL, 59 OUT OF 77 (77%) PATIENTS WERE FREE OF HOSPITALIZATION AND 52% WERE FREE OF ANY VT. SEPTAL-ORIGIN VTS WERE MORE LIKELY TO NEED INA, WHEREAS RV AND PAPILLARY MUSCLE VTS WERE LESS LIKELY TO REQUIRE INA. CONCLUSIONS: REPEAT SRFA WAS BENEFICIAL IN 23% (18/77) OF PATIENTS WITH RECURRENT SUSTAINED VT WHO WERE REFERRED FOR INA. THE AVAILABILITY OF INA INCREASED FAVORABLE OUTCOMES TO 52%. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL® SMARTTOUCH¿ FEMORAL BLEEDING OR ACCESS COMPLICATION OCCURRED, THEREFORE NON-BWI SHEATH WAS REPORTED. CONCOMITANT BIOSENSE WEBSTER DEVICES THAT WERE USED IN THIS STUDY: SOUNDSTAR, CARTO 3 SYSTEM, PENTARAY® NAV, DECANAV CONCOMITANT NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: RECORDING SYSTEM (GE MEDICAL, INC) ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED THERMOCOOL® SMARTTOUCH¿ IN THE STANDARD RFA: QTY 1: ONE PATIENT DEVELOPED A PERICARDIAL EFFUSION FOLLOWING A STEAM POP AT THE BASAL LATERAL MITRAL ANNULUS LV REQUIRING SURGICAL REPAIR. (CARDIAC TAMPONADE) (SURGICAL INTERVENTION) (STEAM POP) (ADVERSE EVENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1799481 THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 10846835008982

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L RECORDING SYSTEM (GE MEDICAL, INC)| UNK_C3 CS REFSTAR - DEFLECTABLE| UNK_CARTO 3| UNK_PENTARAY| UNK_SOUNDSTAR