BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERIC - CELSIUS THERMOCOOL TC

    MDR report key: 6115300 · Received November 18, 2016

    Report

    Report Number
    2029046-2016-00246
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    July 31, 2016
    Report Date
    October 26, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    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. OTHER COMPANY¿S DEVICES WERE USED DURING THIS STUDY: SUBTLE CANNULA (ATRICURE, INC/NCONTACT), NUMERIS OR EPI-SENSE EPICARDIAL ABLATION DEVICE (ATRICURE INC./NCONTACT) (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 PATIENT UNDERWENT RADIOFREQUENCY CATHETER ABLATION FOR ATRIAL FIBRILLATION AND SUFFERED EXPLORATORY LAPAROTOMY TO EVALUATE ABDOMINAL BLEEDING. 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: ¿LONG-TERM SUCCESS FOR THE CONVERGENT ATRIAL FIBRILLATION PROCEDURE: 4-YEAR OUTCOMES.¿ THE PURPOSE OF THIS STUDY WAS TO REPORT LONG-TERM EFFICACY OUTCOMES OF THE CONVERGENT PROCEDURE FOR THE TREATMENT OF ATRIAL FIBRILLATION. THE STUDY WAS CONDUCTED BETWEEN JANUARY 2009 AND JULY 2013. SEVENTY SIX PATIENTS WERE ENROLLED IN THIS STUDY. SUSPECTED DEVICE IS CELSIUS ABLATION CATHETER, HOWEVER CATALOG AND LOT NUMBER ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764597 GENERIC - CELSIUS THERMOCOOL TC SIMILAR DEVICE DI7TCBLRT, PMA # P030031 LPB BIOSENSE WEBSTER, INC. (IRWINDALE) D-1189-00 UNKNOWN_CELSIUS THERMO TC

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other| R