BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 5876267 · Received August 15, 2016

    Report

    Report Number
    9673241-2016-00513
    Event Type
    Injury
    Date Received
    August 15, 2016
    Date of Event
    December 31, 2014
    Report Date
    July 29, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. SINCE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER CANNOT BE PROVIDED. CONCOMITANT PRODUCTS WERE USED DURING THIS STUDY: CARTO. OTHER COMPANY¿S DEVICES WERE USED DURING THIS STUDY: ENSITE NAVX (ST. JUDE MEDICAL INC), DOUBLE TRANSSEPTAL BRK NEEDLE (ST. JUDE MEDICAL INC). (B)(4). THE DEVICE WAS NOT RETURNED TO BWI.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT 1 SYMPTOMATIC PATIENT WITH PERSISTENT ATRIAL FIBRILLATION IN GROUP 3 UNDERWENT RADIOFREQUENCY CATHETER ABLATION AND SUFFERED CARDIAC SURGERY/INTERVENTION. BASED ON THE FACTS OF THE CASE AND THE AUTHOR'S ASSESSMENT, THERE WERE NO REPORTED MALFUNCTION WITH ANY OF THE BWI CATHETERS AND SYSTEMS USED DURING THE CASE. THUS, THIS EVENT IS UNRELATED TO THE DEVICE AND MOST LIKELY RELATED TO THE PROCEDURE. TITLE: "INFLUENCE OF PERIPROCEDURAL ANTICOAGULATION STRATEGIES ON COMPLICATION RATE AND HOSPITAL STAY IN PATIENTS UNDERGOING CATHETER ABLATION FOR PERSISTENT ATRIAL FIBRILLATION." THE PURPOSE OF THIS STUDY WAS TO DETERMINE PERIPROCEDURAL COMPLICATION RATES AMONG THREE OAC STRATEGIES [NOACS, UVKAS, AND INTERRUPTED VKAS (IVKAS)] IN PATIENTS UNDERGOING SOLELY PERSISTENT ATRIAL FIBRILLATION ABLATION. THE STUDY WAS CONDUCTED BETWEEN JANUARY 2011 AND DECEMBER 2014. IRRIGATED-TIP THERMOCOOL, THERMOCOOL SMARTTOUCH, TACTICATH QUARTZ (ST. JUDE MEDICAL) ABLATION CATHETERS WERE USED DURING THIS STUDY. BWI TAKES CONSERVATIVE APPROACH TO REPORT THIS EVENT UNDER SMARTTOUCH THERMOCOOL CATHETER, HOWEVER CATALOG AND LOT NUMBER ARE UNKNOWN. OTHER SERIOUS ADVERSE EVENTS WHICH MENTIONED IN THE ARTICLE WILL BE REPORTED TO FDA SEPARATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528619 THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-00 UNKNOWN_D-1336-00

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention