BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH BIDIRECTIONAL SF

    MDR report key: 12833324 · Received November 17, 2021

    Report

    Report Number
    2029046-2021-01991
    Event Type
    Injury
    Date Received
    November 17, 2021
    Report Date
    November 17, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: SEBAG FA, SIMEON E, MILED M, JORROT P, VILLEJOUBERT O, DARONDEL JM, HAMON D, LELLOUCHE N, MIGNOT N. SINGLE-CATHETER SIMPLIFIED STEPWISE APPROACH TO PERSISTENT ATRIAL FIBRILLATION ABLATION: A FEASIBILITY STUDY. ARCH CARDIOVASC DIS. 2021 OCT 4:S1875-2136(21)00136-4. DOI: 10.1016/J.ACVD.2021.06.012. EPUB AHEAD OF PRINT. PMID: 34620575. 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. 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: SEBAG FA, SIMEON E, MILED M, JORROT P, VILLEJOUBERT O, DARONDEL JM, HAMON D, LELLOUCHE N, MIGNOT N. SINGLE-CATHETER SIMPLIFIED STEPWISE APPROACH TO PERSISTENT ATRIAL FIBRILLATION ABLATION: A FEASIBILITY STUDY. ARCH CARDIOVASC DIS. 2021 OCT 4:S1875-2136(21)00136-4. DOI: 10.1016/J.ACVD.2021.06.012. EPUB AHEAD OF PRINT. PMID: 34620575. OBJECTIVE/METHODS/STUDY DATA:TO EVALUATE THE FEASIBILITY OF THIS APPROACH TO PERFORMING PERSISTENT ATRIAL FIBRILLATION ABLATION, INCLUDING PULMONARY VEIN ISOLATION AND ATRIAL LINES, IF NEEDED. INCLUDED 159 CONSECUTIVE PATIENTS REFERRED TO THE CENTRE FOR A FIRST PERSISTENT ATRIAL FIBRILLATION ABLATION BETWEEN JANUARY 2018 AND DECEMBER 2018. ALL PATIENTS UNDERWENT PULMONARY VEIN ISOLATION. IF THE PATIENT WAS STILL IN ATRIAL FIBRILLATION (SPONTANEOUSLY OR INDUCIBLE), AUTHORS SUBSEQUENTLY PERFORMED A STEPWISE APPROACH, INCLUDING ROOF LINE, ANTERIOR MITRAL LINE, POSTERIOR BOX LESION AND CAVOTRICUSPID ISTHMUS LINE. FINALLY, IF PATIENT REMAINED IN ATRIAL FIBRILLATION AT THE END OF THE PROCEDURE, A SYNCHRONIZED DIRECT-CURRENT CARDIOVERSION WAS APPLIED TO RESTORE SINUS RHYTHM. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH SF (MAPPING AND ABLATION) OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: (QTY 1 ) STROKE/TIA - INTERVENTIONS AND FURTHER DETAILS NOT DISCUSSED (QTY 20) PERICARDIAL EFFUSION/TAMPONADE - INTERVENTIONS AND FURTHER DETAILS NOT DISCUSSED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1723710 UNK_SMART TOUCH BIDIRECTIONAL SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening