BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® THERMOCOOL®

    MDR report key: 3980368 · Received August 5, 2014

    Report

    Report Number
    2029046-2014-00232
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    January 20, 2014
    Report Date
    July 14, 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

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE DEVICE WAS DISPOSED OF AND NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. THEREFORE, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    ARTICLE TITLE: OUTCOMES OF ATRIOESOPHAGEAL FISTULA FOLLOWING CATHETER ABLATION OF ATRIAL FIBRILLATION TREATED WITH SURGICAL REPAIR VERSUS ESOPHAGEAL STENTING. PER A REPORT IN THE JOURNAL: J CARDIOVASC ELECTROPHYSIOL. 2014 JUN;25(6):579-84, A PROSPECTIVE STUDY WAS CONDUCTED ON NINE PATIENTS WITH AEF POST-RFCA FOR AF, BY MOHANTY S OF (B)(6) CARDIAC ARRHYTHMIA INSTITUTE, (B)(6), TO ASSESS OUTCOMES OF ATRIOESOPHAGEAL FISTULA TREATED WITH SURGICAL REPAIR VERSUS ESOPHAGEAL STENTING. MEDIAN FOLLOW-UP TIME: 2.1 YEARS. FROM THE REPORT THERE WERE 4 SERIOUS ADVERSE EVENTS: THE 4 PATIENTS THAT RECEIVED SURGICAL REPAIR WERE ALIVE AT MEDIAN FOLLOW-UP OF 2.1 YEARS. THERE ARE 5 DEATH EVENTS: 5 PATIENTS RECEIVING STENTS DIED WITHIN 1 WEEK OF THE PROCEDURE DUE TO CEREBRAL EMBOLISM, SEPTIC SHOCK, OR RESPIRATORY FAILURE. THERE ARE NO OTHER NON-SERIOUS AE¿S EVENTS OR DEVICE MALFUNCTIONS REPORTED IN THE PUBLICATION. THIS REPORT COVERS PATIENT 9 OF THE ARTICLE. THE (B)(6) MALE, SUFFERING OF PAROXYSMAL ATRIAL FIBRILLATION UNDERWENT RADIOFREQUENCY (RF) ABLATION WITH MAXIMUM POWER OF 25W AND MAXIMUM TEMPERATURE IN ESOPHAGUS OF 39°C. HE RECEIVED PROTON PUMP INHIBITOR (PPI) AND SUCRALFATE BEFORE AND AFTER THE PROCEDURE. FOUR (4) WEEKS LATER HE PRESENTED WITH FEVER, CHEST PAIN, DYSPHAGIA, CONFUSION, LEUKOCYTOSIS, POSTPRANDIAL TIA, MULTIPLE PETECHIAE AND WEAKNESS OF RIGHT ARM. ATRIO-ESOPHAGEAL FISTULA WAS DIAGNOSED AND SURGICAL REPAIR WAS PERFORMED. THE PATIENT WAS ALIVE AT MEDIAN FOLLOW-UP OF 2.1 YEARS. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEVICE IS THE NAVISTAR THERMOCOOL. (1 PATIENT WITH THERMOCOOL SF AND 7 WITH STANDARD THERMOCOOL IRRIGATED TIP CATHETER) AND IN 1 PATIENT ABLATION WAS PERFORMED USING NON IRRIGATED 8-MM TIP CELSIUS CATHETER. IN 1 PATIENT ONLY SURGICAL EPICARDIAL ABLATION WAS PERFORMED. NO CONCOMITANT PRODUCTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456608 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 56 YR Life Threatening| R