BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® THERMOCOOL®

    MDR report key: 4037430 · Received August 26, 2014

    Report

    Report Number
    2029046-2014-00280
    Event Type
    Injury
    Date Received
    August 26, 2014
    Date of Event
    December 1, 2012
    Report Date
    August 1, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. CONCOMITANT BWI PRODUCTS: PRODUCT: CARTO® 3 SYSTEM, US CATALOG # FG540000, SERIAL # UNKNOWN. PRODUCT: COOLFLOW® IRRIGATION PUMP, US CATALOG # CFP002, SERIAL # UNKNOWN. PRODUCT: CIRCUMFERENTIAL DECAPOLAR DIAGNOSTIC CATHETER LASSO, US CATALOG # UNKNOWN, LOT # UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    THIS IS A MULTI-CENTER STUDY. A TOTAL OF 1134 CONSECUTIVE PATIENTS UNDERWENT A FIRST CATHETER ABLATION PROCEDURE OF PAF BETWEEN JUNE 2008 AND DECEMBER 2012. THE AIM OF THIS STUDY WAS TO INVESTIGATE IF PATIENTS WITH PAF AND SUSTAINED AF ACUTELY AFTER PVI MIGHT BENEFIT FROM ADDITIONAL COMPLEX FRACTIONATED ATRIAL ELECTROGRAM (CFAE) ABLATION. FROM THE REPORT: ONE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT WAS SUCCESSFULLY TREATED BY PERICARDIOCENTESIS. NO OTHER PROCEDURE-RELATED COMPLICATION OCCURRED. RADIOFREQUENCY (RF) CURRENT WAS DELIVERED WITH A 3.5-MM OPEN-IRRIGATED CATHETER. MODEL AND CATALOG NUMBER OF ABLATION CATHETERS ARE NOT AVAILABLE. SUSPICIOUS DEVICE IS NAVISTAR THERMOCOOL. THE FOLLOWING BWI PRODUCTS ALSO WERE USED DURING THE PROCEDURE: A CIRCUMFERENTIAL DECAPOLAR DIAGNOSTIC CATHETER LASSO; CARTO SYSTEM AND COOLFLOW PUMP. ALSO NON BWI PRODUCTS WERE USED DURING THE PROCEDURE: A COMPUTER-BASED DIGITAL AMPLIFIER/RECORDER SYSTEM (BARD ELECTROPHYSIOLOGY, (B)(4)). A STEERABLE DECAPOLAR CATHETER (INQUIRY, IRVINE BIOMEDICAL INC, (B)(4)); A NONSTEERABLE QUADRIPOLAR DIAGNOSTIC CATHETER (INQUIRY,IBI, IRVINE BIOMEDICAL) ENSITE NAVX (STJUDE MEDICAL, (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517399 NAVISTAR® THERMOCOOL® CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC (IRWINDALE) NAVISTAR THERMOCOOL UNKNOWN_NAVISTAR THERMO TC

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening| R