BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 17168732 · Received June 21, 2023

    Report

    Report Number
    2029046-2023-01339
    Event Type
    Injury
    Date Received
    June 21, 2023
    Date of Event
    January 10, 2023
    Report Date
    June 21, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009163
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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: VAN DER HEIJDEN CAJ, WEBERNDÖRFER V, VROOMEN M, LUERMANS JG, CHALDOUPI SM, BIDAR E, VERNOOY K, MAESSEN JG, PISON L, VAN KUIJK SMJ, LA MEIR M, CRIJNS HJGM, MAESEN B. HYBRID ABLATION VERSUS REPEATED CATHETER ABLATION IN PERSISTENT ATRIAL FIBRILLATION: A RANDOMIZED CONTROLLED TRIAL. JACC CLIN ELECTROPHYSIOL. 2023 JAN 10:S2405-500X(22)01143-4. DOI: 10.1016/J.JACEP.2022.12.011. EPUB AHEAD OF PRINT. PMID: 36752455. 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: VAN DER HEIJDEN CAJ, WEBERNDÖRFER V, VROOMEN M, LUERMANS JG, CHALDOUPI SM, BIDAR E, VERNOOY K, MAESSEN JG, PISON L, VAN KUIJK SMJ, LA MEIR M, CRIJNS HJGM, MAESEN B. HYBRID ABLATION VERSUS REPEATED CATHETER ABLATION IN PERSISTENT ATRIAL FIBRILLATION: A RANDOMIZED CONTROLLED TRIAL. JACC CLIN ELECTROPHYSIOL. 2023 JAN 10:S2405-500X(22)01143-4. DOI: 10.1016/J.JACEP.2022.12.011. EPUB AHEAD OF PRINT. PMID: 36752455. OBJECTIVE/METHODS/STUDY DATA:THE PURPOSE OF THIS STUDY WAS TO COMPARE THE EFFECTIVENESS AND SAFETY OF HA WITH CA IN A PROSPECTIVE, SUPERIORITY, UNBLINDED, RANDOMIZED CONTROLLED TRIAL. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: HYBRID PROCEDURE (HA): 3.5-MM TIP ABLATION CATHETER (THERMOCOOL SMARTTOUCH, BIOSENSE WEBSTER) OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CATHETER ABLATION (CA): AN IRRIGATED TIP CONTACT FORCE MAPPING CATHETER (THERMOCOOL SMARTTOUCH, BIOSENSE WEBSTER), AUTOMATED LESION TAGGING (VISITAG, BIOSENSE WEBSTER) NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: BIPOLAR RADIOFREQUENCY (RF)-CLAMP (SYNERGY SYSTEM, ATRICURE), UNIDIRECTIONAL BIPOLAR RF PEN (COOLRAIL, ATRICURE), EPICARDIAL CLIPPING DEVICE (ATRICLIP PRO OR ATRICLIP PRO 2, ATRICURE) OR AN LAA CLOSURE DEVICE (LARIAT, SENTREHEART), ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: IN THE HA, 1 PATIENT HAD A PERICARDITIS REQUIRING PERICARDIOCENTESIS. IN THE HA GROUP - 1 PATIENT UNDERWENT A STAGED EPI/ENDOCARDIAL PROCEDURE DUE TO MALFUNCTION OF THE EQUIPMENT FOR THE ENDOCARDIAL ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2216357 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D132701 10846835009163

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other (THERMOCOOL SMARTTOUCH, BIOSENSE WEBSTER.| BIPOLAR RF-CLAMP (SYNERGY SYSTEM, ATRICURE).| EPICARDIAL DEV (ATRICLIP PRO OR PRO 2, ATRICURE).| LAA CLOSURE DEVICE (LARIAT, SENTREHEART).| UNIDIRECTIONALBIPOLAR RF PEN (COOLRAIL, ATRICURE).| VISITAG, BIOSENSE WEBSTER.