BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERIC - CELSIUS THERMOCOOL TC

    MDR report key: 6024911 · Received October 12, 2016

    Report

    Report Number
    2029046-2016-00221
    Event Type
    Injury
    Date Received
    October 12, 2016
    Date of Event
    June 30, 2016
    Report Date
    September 20, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    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. OTHER COMPANY'S WERE USED IN THIS STUDY: RHYTHMIA, BOSTON SCIENTIFIC, (B)(4); INTELLAMAP ORION, BOSTON SCIENTIFIC, (B)(4); SL1, ST. JUDE MEDICAL INC, (B)(4); 4 MM BLAZER, BOSTON SCIENTIFIC, (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 ONE PATIENT DEVELOPED PERICARDIAL TAMPONADE 3 H AFTER THE PROCEDURE, WHICH COULD BE SUCCESSFULLY DRAINED (VENOUS BLOOD) WITHOUT SEQUELAE. 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:"FIRST CLINICAL EXPERIENCE USING A NOVEL HIGH-RESOLUTION ELECTROANATOMICAL MAPPING SYSTEM FOR LEFT ATRIAL ABLATION PROCEDURES." THE PURPOSE OF THIS STUDY WAS TO DETERMINE THE ACUTE PROCEDURAL EFFICACY AND SAFETY OF THIS NEW SYSTEM (RHYTHMIA MAPPING SYSTEM) IN A LARGER PATIENT COHORT WITH ATRIAL FIBRILLATION (AF) AND LEFT ATRIAL TACHYCARDIA (AT). 35 CONSECUTIVE PATIENTS UNDERWENT CATHETER ABLATION FOR AF AND/OR AT. SUSPECTED DEVICE IS THERMOCOOL CELSIUS; HOWEVER CATALOG AND LOT NUMBER ARE UNKNOWN. OTHER COMPANY'S WERE USED IN THIS STUDY: RHYTHMIA, BOSTON SCIENTIFIC, (B)(4); INTELLAMAP ORION, BOSTON SCIENTIFIC, (B)(4); SL1, ST. JUDE MEDICAL INC, (B)(4); 4 MM BLAZER, BOSTON SCIENTIFIC, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674487 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 64 YR Life Threatening| R