BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 18891806 · Received March 12, 2024

    Report

    Report Number
    2029046-2024-00818
    Event Type
    Injury
    Date Received
    March 12, 2024
    Date of Event
    November 17, 2022
    Report Date
    March 12, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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: IBRAHIM DÖNMEZ, TOLGA MEMIOGLU, EMRAH ACAR, FATMA ERDEM. EVALUATION OF THE EFFECTS OF 3D MAPPING ABLATION ON ATRIAL CONDUCTION TIMES IN PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION. ANN CLIN ANAL MED 2022;13(12):1373-1377. 2022 NOV 17. DOI: 10.4328/ACAM.21367. 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 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 REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: IBRAHIM DÖNMEZ, TOLGA MEMIOGLU, EMRAH ACAR, FATMA ERDEM. EVALUATION OF THE EFFECTS OF 3D MAPPING ABLATION ON ATRIAL CONDUCTION TIMES IN PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION. ANN CLIN ANAL MED 2022;13(12):1373-1377. 2022 NOV 17. DOI: 10.4328/ACAM.21367. OBJECTIVE/METHODS/STUDY DATA: AIM: ATRIAL FIBRILLATION (AF) CAUSES STRUCTURAL, ELECTRICAL, AND CELLULAR REMODELING IN THE ATRIUM. EVALUATION OF INTRA- AND INTERATRIAL CONDUCTION TIME, INDICATES STRUCTURAL AND ELECTRICAL REMODELING IN THE ATRIUM. THIS STUDY AIMED TO EVALUATE THE EFFECT OF PULMONARY VEIN ISOLATION APPLIED WITH RADIOFREQUENCY ABLATION (RF) THERAPY ON INTRA- AND INTERATRIAL CONDUCTION TIME AND TO INVESTIGATE THE STRUCTURAL AND ELECTRICALLY REMODELING AFTER TREATMENT. MATERIAL AND METHODS: FIFTY-TWO PATIENTS WITH SYMPTOMATIC PAF DESPITE AT LEAST ONE ANTIARRHYTHMIC DRUG AND WITHOUT STRUCTURAL HEART DISEASE WERE INCLUDED IN THE STUDY. TWO PATIENTS WERE EXCLUDED BECAUSE OF COMPLICATIONS DEVELOPED DURING AND AFTER THE OPERATION. FIFTY PATIENTS (28 FEMALE; MEAN AGE: 51.68 ± 11.731; MEAN LEFT ATRIAL DIAMETER: 36.79 ± 4.318) WHO UNDERWENT CARTO® 3D PULMONARY VEIN ISOLATION APPLIED WITH THE RF ABLATION SYSTEM WERE FOLLOWED-UP. INTRA- AND INTER-ATRIAL ELECTROMECHANICAL DELAY WAS MEASURED IN ALL PATIENTS USING TISSUE DOPPLER ECHOCARDIOGRAPHY BEFORE AND THREE MONTHS AFTER RF ABLATION. RESULTS: ALL INTRA- AND INTERATRIAL CONDUCTION TIMES WERE SIGNIFICANTLY DECREASED 3 MONTHS AFTER RF ABLATION PROCEDURE (PA LATERAL P = 0.022; PA SEPTUM P =0.002; PA TRICUSPID P = 0.019, INTERATRIAL CONDUCTION DELAY P= 0,012, INTRA-ATRIAL CONDUCTION DELAY P = 0.029). DISCUSSION: THE RESULTS OF THE STUDY SUGGEST THAT PROVIDING STABLE SINUS RHYTHM WITH RF ABLATION MAY SLOW DOWN, STOP OR EVEN IMPROVE STRUCTURAL REMODELING AT SUBSTRATE LEVEL SECONDARY TO AF EVEN IN PATIENTS WITH PAROXYSMAL AF WHO DID NOT YET DEVELOP ATRIAL FIBROSIS AND PERMANENT STRUCTURAL CHANGES. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH SF. BIOSENSE WEBSTER DEVICES THAT WERE USED IN THIS STUDY: LASSO MAPPING CATHETER, CARTO 3D SYSTEM. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: BROCKENBROUGH NEEDLE (ST. JUDE). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED THERMOCOOL SMARTTOUCH SF ABLATION CATHETER: QTY 1 ACUTE PERICARDIAL TAMPONADE (CARDIAC TAMPONADE) (RECOGNIZED PROCEDURAL COMPLICATION) DURING 3D PULMONARY VEIN ISOLATION AND THE PROCESS WAS TERMINATED. QTY 1 PERICARDIAL TAMPONADE (CARDIAC TAMPONADE) WAS OBSERVED 12 HOURS AFTER THE SUCCESSFUL PROCESS THEN THE PATIENT WAS TAKEN TO THE SURGERY (SURGICAL INTERVENTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162592 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L