BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 15587868 · Received October 12, 2022

    Report

    Report Number
    2029046-2022-02497
    Event Type
    Injury
    Date Received
    October 12, 2022
    Date of Event
    February 12, 2020
    Report Date
    October 12, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. HASSAN WS, ZAKY SH, MOHAMED KH, IBRAHIM MM. SMART TOUCH RADIOFREQUENCY CATHETER ABLATION VERSUS CRYOBALLOON ABLATION OF PULMONARY VEINS IN PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION. OPEN ACCESS MACED J MED SCI. 2020 AUG 15; 8(B):563-568. HTTPS://DOI. ORG/10.3889/OAMJMS.2020.444. 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 NOT 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. THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER APPROVED UNDER PMA # (B)(4). MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. HASSAN WS, ZAKY SH, MOHAMED KH, IBRAHIM MM. SMART TOUCH RADIOFREQUENCY CATHETER ABLATION VERSUS CRYOBALLOON ABLATION OF PULMONARY VEINS IN PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION. OPEN ACCESS MACED J MED SCI. 2020 AUG 15; 8(B):563-568. HTTPS://DOI. ORG/10.3889/OAMJMS.2020.444. OBJECTIVE/METHODS/STUDY DATA: : EVALUATION OF THE SAFETY AND EFFICACY OF PULMONARY VEINS ISOLATION IN PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION (AF) USING TWO NEW DIFFERENT TECHNOLOGIES, CRYOBALLOON (CB) ABLATION AND RADIOFREQUENCY ABLATION WITH CONTACT FORCE (CF)-SENSING CATHETERS. PROSPECTIVE SINGLE-CENTER EVALUATION, CARRIED OUT FROM JANUARY 2016 TO JUNE 2018 IN CRITICAL CARE MEDICINE DEPARTMENT ¿ CAIRO UNIVERSITY, COMPARING CF RADIOFREQUENCY (THERMOCOOL® SMARTTOUCH, BIOSENSE WEBSTER, INC.) (CF GROUP) WITH CB ABLATION (ARCTIC FRONT ADVANCE 28 MM CB, MEDTRONIC, INC.) (CB GROUP), IN REGARDS TO PROCEDURAL SAFETY AND EFFICACY, AS WELL AS RECURRENCE AT 12 MONTHS. OVERALL, 50 CONSECUTIVE PATIENTS WERE ENROLLED (25 IN EACH GROUP). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: MAPPING CATHETER (CMC; LASSOTM; BIOSENSE WEBSTER) , CMC (LASSO, BIOSENSE WEBSTER). NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: 14-FR DEFLECTABLE SHEATH(FLEXCATH, MEDTRONIC) , CIRCULAR ACHIEVE CATHETER (MEDTRONIC) , CRYOBALLOON ABLATION CATHETER (MEDTRONIC). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS . QTY 1 PERICARDIAL EFFUSION AND TAMPONADE REQUIRED SURGICAL REPAIR OF THE LAA ( CF GROUP). QTY 1 ENTRAPMENT OF CIRCULAR MAPPING CATHETER INTO THE MITRAL VALVE CHORDAE REQUIRED SURGICAL INTERVENTION ( CF GROUP) THIS EVENT WILL BE CODED AS SOFT TISSUE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2887372 THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| L 14-FR DEFLECTABLE SHEATH(FLEXCATH, MEDTRONIC)| CIRCULAR ACHIEVE CATHETER (MEDTRONIC)| CMC (LASSO, BIOSENSE WEBSTER)| CRYBALLON ABLATION CATHETER (MEDTRONIC)| MAPPING CATHETER (CMC, LASSOTM, BWI)