BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 20707668 · Received November 18, 2024

    Report

    Report Number
    2029046-2024-03708
    Event Type
    Injury
    Date Received
    November 18, 2024
    Date of Event
    September 12, 2024
    Report Date
    November 18, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S072
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: AKDIS D, WEIDMANN L, GUAN F, BACHMANN M, WINNIK S, DURU F, ERIKSSON U. CLINICAL EXPERIENCE OF PULMONARY VEIN ISOLATION VIA SINGLE TRANSSEPTAL PUNCTURE IN ATRIAL FIBRILLATION PATIENTS: COMPREHENSIVE CHARACTERIZATION AND FOLLOW-UP. INT J CARDIOL. 2024 SEP 12;418:132557. DOI: 10.1016/J.IJCARD.2024.132557. EPUB AHEAD OF PRINT. PMID: 39276818. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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: AKDIS D, WEIDMANN L, GUAN F, BACHMANN M, WINNIK S, DURU F, ERIKSSON U. CLINICAL EXPERIENCE OF PULMONARY VEIN ISOLATION VIA SINGLE TRANSSEPTAL PUNCTURE IN ATRIAL FIBRILLATION PATIENTS: COMPREHENSIVE CHARACTERIZATION AND FOLLOW-UP. INT J CARDIOL. 2024 SEP 12;418:132557. DOI: 10.1016/J.IJCARD.2024.132557. EPUB AHEAD OF PRINT. PMID: 39276818. OBJECTIVE/METHODS/STUDY DATA: THE OBJECTIVE OF THE STUDY WAS TO ASSESS THE EFFICACY, SAFETY AND LONG-TERM OUTCOME OF PATIENTS UNDERGOING PVI FOR PAROXYSMAL, PERSISTENT OR LONG-STANDING PERSISTENT AF, WHO RECEIVED THIS ABLATION PROCEDURE AT TWO CARDIOLOGY CENTRES IN SWITZERLAND. BETWEEN JANUARY 1, 2017 AND MAY 30, 2022, A TOTAL OF 304 PATIENTS (186 MALE AND 118 FEMALE) WITH A MEAN AGE OF 67 YEARS. THESE PATIENTS UNDERWENT A SINGLE TRANSSEPTAL PUNCTURE (STP)-ABLATION TECHNIQUE WHERE 248 PATIENTS UNDERWENT DE NOVO PULMONARY VEIN ISOLATION (PVI), WITH 235 OF THEM HAD THE TRANSSEPTAL PUNCTURES GUIDED BY TRANSESOPHAGEAL ECHOCARDIOGRAPHY. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNKNOWN THERMOCOOL. OTHER DEVICES THAT WERE USED ON THE PATIENT AT THE TIME OF THE EVENT: CARTO® MAPPING SYSTEM (BIOSENSE WEBSTER), CUSTOMED SOFTWARE CARTO® MERGE (BIOSENSE WEBSTER), PENTARAY, AND/OR LASSO CATHETER. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK_THERMOCOOL SF NON NAV (QTY. 4) = 1 PATIENT DEVELOPED PERICARDITIS WITH NO REPORTED INTERVENTION DONE = 3 PATIENTS HAD TRANSIENT PULMONARY EDEMA AND/OR DECOMPENSATED HEART FAILURE OCCURRED WITH NO REPORTED INTERVENTION DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2036547 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other UNK_CARTO 3| UNK_LASSOSTAR CATHETER| UNK_PENTARAY