BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 17655123 · Received August 30, 2023

    Report

    Report Number
    2029046-2023-01944
    Event Type
    Death
    Date Received
    August 30, 2023
    Date of Event
    February 9, 2023
    Report Date
    August 30, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010145
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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- KAWAJI T, AIZAWA T, MATSUDA S, KATO M, YOKOMATSU T, MIKI S. GROWING THROMBUS ADHESION ON THE LEFT ATRIAL WALL AFTER CATHETER ABLATION OF ATRIAL FIBRILLATION. J ARRHYTHMIA. 2023;39:467¿469. HTTPS://DOI.ORG/10.1002/ JOA3.12849. 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- KAWAJI T, AIZAWA T, MATSUDA S, KATO M, YOKOMATSU T, MIKI S. GROWING THROMBUS ADHESION ON THE LEFT ATRIAL WALL AFTER CATHETER ABLATION OF ATRIAL FIBRILLATION. J ARRHYTHMIA. 2023;39:467¿469. HTTPS://DOI.ORG/10.1002/ JOA3.12849. OBJECTIVE/METHODS/STUDY DATA:THE STUDY IS INTENDED TO EVALUATE THE A CASE OF A GROWING AND MASSIVE THROMBUS ADHESION AT THE ABLATION SITE DETECTED BY CONTRAST COMPUTED TOMOGRAPHY (CT). AN 80-YEAR-OLD JAPANESE MAN UNDERWENT RADIOFREQUENCY CATHETER ABLATION OF DRUG-REFRACTORY SYMPTOMATIC PAROXYSMAL AF. HIS RENAL FUNCTION DECREASED (CCR 41 ML/MIN), BUT CARDIAC FUNCTION EVALUATED BY TRANSTHORACIC ECHOCARDIOGRAPHY WAS ALMOST NORMAL (LEFT VENTRICULAR EJECTION FRACTION = 66.8%, LA DIMENSION = 38 MM).TO OBTAIN A COMPLETE PV ISOLATION AND BLOCK OF THE LA ROOF LINE, NUMEROUS ADDITIONAL ABLATION APPLICATIONS WERE REQUIRED. HE WAS DISCHARGED WITHOUT ANY COMPLICATIONS OR RECURRENT. ATRIAL TACHYARRHYTHMIAS ON POSTOPERATIVE DAY (POD) 2. NO THROMBUS WAS DETECTED IN TRANSTHORACIC ECHOCARDIOGRAPHY IMAGE ON POD 1. ON POD 8, HE VISITED THE EMERGENCY ROOM WITH CHEST PAIN. A NONGATED CONTRAST CT IMAGE DEMONSTRATED A COMPLETE FILLING DEFECT, WITH A SUSPECTED THROMBUS, MAINLY ON THE LA POSTERIOR WALL. HE EXPERIENCED THE FIRST ATTACK OF AN ISCHEMIC STROKE THE NEXT DAY. THE OAC WAS CHANGED TO DABIGATRAN 220 MG/DAY AFTER THE FIRST ATTACK, ALTHOUGH A SECOND ISCHEMIC STROKE ATTACK WITH SPLENIC INFARCTS OCCURRED WITHOUT RECURRENCE OF ATRIAL TACHYARRHYTHMIAS ON POD 32. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH SF®, BIOSENSE WEBSTER, INC OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO® SYSTEM. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS QTY 1 -THROMBUS MANAGED WITH ANTICOAGULANTS; QTY 1 - ISCHEMIC STROKE MANAGED WITH ANTICOAGULANTS; QTY 1- DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1492685 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 10846835010145

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Death| S CARTO® SYSTEM