BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH BIDIRECTIONAL

    MDR report key: 15481949 · Received September 25, 2022

    Report

    Report Number
    2029046-2022-02311
    Event Type
    Injury
    Date Received
    September 25, 2022
    Date of Event
    January 1, 2020
    Report Date
    September 25, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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: HUANG, J., DING, L., LIGANG, L. ET AL. INCIDENCE, CAUSES AND MANAGEMENT STRATEGIES OF PERICARDIAL TAMPONADE DURING CATHETER ABLATION FOR ARRHYTHMIA: A SINGLE CENTER EXPERIENCE. CHINESE CIRCULATION JOURNAL, 2020, 35:62. 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 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: HUANG, J., DING, L., LIGANG, L. ET AL. INCIDENCE, CAUSES AND MANAGEMENT STRATEGIES OF PERICARDIAL TAMPONADE DURING CATHETER ABLATION FOR ARRHYTHMIA: A SINGLE CENTER EXPERIENCE. CHINESE CIRCULATION JOURNAL, 2020, 35:62. OBJECTIVE/METHODS/STUDY DATA: OBJECTIVES: TO ANALYZE THE INCIDENCE, RISK FACTORS, AND OUTCOME AND TO EXPLORE MORE EFFECTIVE PREVENTION AND TREATMENT OPTIONS OF PERICARDIAL TAMPONADE DURING CATHETER ABLATION FOR ARRHYTHMIA. METHODS: A TOTAL OF 2,211 PATIENTS WHO UNDERWENT CATHETER ABLATION FROM JANUARY 2016 TO DECEMBER 2018 IN THE ARRHYTHMIA CENTER OF OUR HOSPITAL WERE RETROSPECTIVELY ANALYZED. RESULTS: OF THE 2211 PATIENTS WHO UNDERWENT RADIOFREQUENCY CATHETER ABLATION, 934 PATIENTS WITH SUPRAVENTRICULAR TACHYCARDIA HAD NO CARDIAC TAMPONADE; 10 (1.41%) OF THE 707 PATIENTS WITH ATRIAL ARRHYTHMIA HAD CARDIAC TAMPONADE, OF WHICH 9 HAD CARDIAC TAMPONADE DURING THE OPERATION DUE TO THE USE OF NON-PRESSURE CATHETER; 5 (0.88%) OF THE 570 PATIENTS WITH VENTRICULAR ARRHYTHMIA HAD CARDIAC TAMPONADE. - RESULTS: AMONG 15 PATIENTS WITH CARDIAC TAMPONADE, 5 (33.3%) HAD ARRHYTHMIA, OF WHICH 3 WERE TREATED WITH SAFIRE CATHETER, 1 WITH SMARTTOUCH CATHETER AND 1 WITH COOLFLEX CATHETER. CONCLUSION: THE INCIDENCE OF CARDIAC TAMPONADE IN RADIOFREQUENCY CATHETER ABLATION OF ARRHYTHMIA IS LOW, AND ITS INCIDENCE IS RELATED TO ATRIAL FIBRILLATION ABLATION, OPERATION INJURY AND PRESSURE MONITORING. IT IS ALSO ASSOCIATED WITH FOCAL WEAKNESS AT SPECIFIC ANATOMICAL SITES (E.G. RVOT FREE WALL, LA ROOF, ETC.) OR DIFFICULTY IN STABLE CATHETER APPOSITION, RESULTING IN EXCESSIVE ABLATION. MOST CARDIAC TAMPONADES HAVE A GOOD PROGNOSIS AFTER PERICARDIOCENTESIS DRAINAGE, AND A SMALL NUMBER OF PATIENTS SHOULD UNDERGO SURGICAL REPAIR AS EARLY AS POSSIBLE IF THEY HAVE HEMODYNAMIC INSTABILITY DURING MONITORING TO AVOID ADVERSE OUTCOMES. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SMARTTOUCH CATHETER. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO3. ENSITE SYSTEM. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: SAFIRE CATHETER, COOLFLEX CATHETER, HUITAI ABLATION CATHETER. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: ONE 74-OLD-YEAR-OLD PATIENT SUFFERED AN ARRHYTHMIA AND CARDIAC TAMPONADE; NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2533272 UNK_SMART TOUCH BIDIRECTIONAL CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening CARTO3| COOLFLEX CATHETER| ENSITE SYSTEM| HUITAI ABLATION CATHETER| SAFIRE CATHETER