BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_THERMOCOOL SF NAV

    MDR report key: 14104985 · Received April 13, 2022

    Report

    Report Number
    2029046-2022-00796
    Event Type
    Injury
    Date Received
    April 13, 2022
    Date of Event
    July 31, 2017
    Report Date
    April 13, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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: U-SHAPED RELATIONSHIP BETWEEN LEFT ATRIUM SIZE ON ECHOCARDIOGRAPHY AND 1-YEAR RECURRENCE OF ATRIAL FIBRILLATION AFTER RADIOFREQUENCY CATHETER ABLATION. PMID: 31178525 DOI: 10.1253/CIRCJ.CJ-19-0167. 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 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: U-SHAPED RELATIONSHIP BETWEEN LEFT ATRIUM SIZE ON ECHOCARDIOGRAPHY AND 1-YEAR RECURRENCE OF ATRIAL FIBRILLATION AFTER RADIOFREQUENCY CATHETER ABLATION. PMID: 31178525 DOI: 10.1253/CIRCJ.CJ-19-0167. OBJECTIVE/METHODS/STUDY DATA: SUBJECTS: THE LARGER THE LEFT ATRIUM ANTEROPOSTERIOR DIMENSION (LAD) AND LEFT ATRIUM VOLUME (LAV), THE STRONGER THE ASSOCIATION WITH RECURRENT ATRIAL FIBRILLATION (AF) AFTER RADIOFREQUENCY CATHETER ABLATION (RFCA). PATIENTS WITH A SMALLER LEFT ATRIUM (LA) SIZE, HOWEVER, ALSO HAVE INCREASED AF RECURRENCE. SUCCESSIVE RANGES OF LAD AND LAV AND THE SUBSEQUENT RISK FOR AF RECURRENCE WERE EVALUATED, IN ORDER TO CLARIFY THE RELATIONSHIP BETWEEN LA SIZE AND THE RECURRENCE OF AF 1 YEAR AFTER RFCA. METHODS: THIS PROSPECTIVE OBSERVATIONAL STUDY ENROLLED 542 CONSECUTIVE PATIENTS WITH PAROXYSMAL OR PERSISTENT AF WHO UNDERWENT RFCA AT THE PRESENT INSTITUTION BETWEEN JANUARY 2015 AND JULY 2017. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: ABLATION CATHETER THERMOCOOL; BIOSENSE WEBSTER CONCOMITANT OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO 3; BIOSENSE WEBSTER. CONCOMITANT NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: IT WAS REPORTED THAT 7 PATIENTS WHO UNDERWENT CATHETER ABLATION (CA) WITH ABLATION CATHETER THERMOCOOL HAVE DEVELOPED PSEUDOANEURYSMS. 4 PATIENTS WHO UNDERWENT CATHETER ABLATION (CA) WITH ABLATION CATHETER THERMOCOOL HAVE EXPERIENCED SINUS ARREST AND WERE TREATED WITH PACEMAKERS IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654403 UNK_THERMOCOOL SF NAV CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| L CARTO 3 SYSTEM