BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 17663420 · Received August 31, 2023

    Report

    Report Number
    2029046-2023-01960
    Event Type
    Injury
    Date Received
    August 31, 2023
    Date of Event
    December 12, 2019
    Report Date
    August 31, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    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

    MANUFACTURER'S REF. NO: (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE-THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED- REDDY VY, SCHILLING R, GRIMALDI M, HORTON R, NATALE A, RIVA S, TONDO C, KUCK KH, NEUZIL P, MCINNIS K, BISHARA M, ZHANG B, GOVARI A, ABDELAAL A, MANSOUR M. PULMONARY VEIN ISOLATION WITH A NOVEL MULTIELECTRODE RADIOFREQUENCY BALLOON CATHETER THAT ALLOWS DIRECTIONALLY TAILORED ENERGY DELIVERY: SHORT-TERM OUTCOMES FROM A MULTICENTER FIRST-IN-HUMAN STUDY (RADIANCE). CIRC ARRHYTHM ELECTROPHYSIOL. 2019 DEC;12(12):E007541. DOI: 10.1161/CIRCEP.119.007541. EPUB 2019 DEC 12. PMID: 31826648. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS NOT 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE-THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED- REDDY VY, SCHILLING R, GRIMALDI M, HORTON R, NATALE A, RIVA S, TONDO C, KUCK KH, NEUZIL P, MCINNIS K, BISHARA M, ZHANG B, GOVARI A, ABDELAAL A, MANSOUR M. PULMONARY VEIN ISOLATION WITH A NOVEL MULTIELECTRODE RADIOFREQUENCY BALLOON CATHETER THAT ALLOWS DIRECTIONALLY TAILORED ENERGY DELIVERY: SHORT-TERM OUTCOMES FROM A MULTICENTER FIRST-IN-HUMAN STUDY (RADIANCE). CIRC ARRHYTHM ELECTROPHYSIOL. 2019 DEC;12(12):E007541. DOI: 10.1161/CIRCEP.119.007541. EPUB 2019 DEC 12. PMID: 31826648. OBJECTIVE/METHODS/STUDY DATA:THE STUDY AIMED TO EVALUATE THE FEASIBILITY, SAFETY, AND SHORT-TERM EFFICACY OF THIS RADIOFREQUENCY BALLOON IN A MULTICENTER,SINGLE-ARM, FIRST-IN-HUMAN STUDY. PAROXYSMAL ATRIAL FIBRILLATION PATIENTS UNDERWENT PV ISOLATION WITH THE RADIOFREQUENCY BALLOON DELIVERED OVER-THE-WIRE WITH A DEFLECTABLE 13.5F SHEATH. RADIOFREQUENCY ENERGY IS DELIVERED SIMULTANEOUSLY FROM ALL ELECTRODES-UP TO 30 S POSTERIORLY AND 60 S ANTERIORLY. ESOPHAGEAL TEMPERATURE WAS MONITORED IN ALL PATIENTS; THE ESOPHAGUS WAS ALSO MECHANICALLY DEVIATED IN 10 PATIENTS. AT 4 SITES, 39 PATIENTS WERE TREATED BY 9 OPERATORS. THE RADIOFREQUENCY BALLOON ISOLATED ALL TARGETED PVS (152/152), 79.6% WITH A SINGLE APPLICATION. ELECTRICAL RECONNECTION OCCURRED IN ONLY 7/150 PVS (4.7%) ON ADENOSINE/ISOPROTERENOL CHALLENGE. MEAN PROCEDURE, BALLOON DWELL, AND FLUOROSCOPY TIMES WERE 101.6, 40.5, AND 17.4 MIN, RESPECTIVELY. ESOPHAGOGASTRODUODENOSCOPY REVEALED ASYMPTOMATIC ESOPHAGEAL ERYTHEMA IN 5 PATIENTS. PHRENIC NERVE PALSY OCCURRED IN A PATIENT IN WHOM PHRENIC PACING WAS INADVERTENTLY OMITTED. AT 3 MONTHS, IMAGING REVEALED NO PV STENOSIS, AND EARLY ATRIAL ARRHYTHMIA RECURRENCE OCCURRED IN ONLY 10/39 (25.6%) PATIENTS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: RFB ( RADIOFREQUENCY BALLOON IRRIGATED ABLATION CATHETER (MULTIELECTRODE RF BALLOON CATHETER, BIOSENSE WEBSTER INC, IRVINE, CA). OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CIRCULAR MAPPING CATHETER (LASSO, BIOSENSE WEBSTER INC), CARTO SYSTEM, NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: QTY 1- PHRENIC NERVE PARALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1603593 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other CARTO SYSTEM| CIRCULAR MAPPING CATHETER (LASSO, BIOSENSE)| RFB ( RADIOFREQUENCY BALLOON IRRIGATED CATHETER