BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TCOOL SF CARTO XP UNI, TC, F

    MDR report key: 7387236 · Received March 30, 2018

    Report

    Report Number
    2029046-2018-01384
    Event Type
    Injury
    Date Received
    March 30, 2018
    Date of Event
    February 28, 2016
    Report Date
    March 27, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM AUTHOR INDICATING THAT DEVICES WITH CATALOG D131803 MAY BE THE ONE THAT USED IN THIS STUDY IN 2016, THE EVENT IS POSSIBLE DEVICE RELATED AND PROCEDURE RELATED. THE EVENT RESULTED IN MILD DAMAGE TO OESOPHAGUS, HOWEVER IT DID NOT REQUIRE ANY INTERVENTION OR TREATMENT. PATIENT IS FULLY RECOVERED. MANUFACTURER'S REF.: (B)(4).

    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. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT ONE PATIENT UNDERWENT RADIOFREQUENCY ABLATION FOR ATRIAL FIBRILLATION AND HAD A SINGLE ESOPHAGEAL THERMAL LESION WITH CLEARLY VISIBLE ERYTHEMA AND MUCOSAL DISRUPTION. THAT PATIENT EXPERIENCED A TEMPERATURE PEAK OF 53.2°C AND DURING ONE RADIOFREQUENCY APPLICATION EXPERIENCED NEARLY 2 MINUTES WITH TEMPERATURE PEAK >40°C. PATIENT WAS CAREFULLY MONITORED, PLACED ON A PROTON PUMP INHIBITOR, AND SCHEDULED FOR A FULL FOLLOW-UP ENDOSCOPY WITHIN 2 WEEKS. AT FOLLOW-UP ENDOSCOPY, ALL ESOPHAGEAL LESIONS HAD FULLY RESOLVED, AND THERE WERE NO REMAINING SIGNS OR SYMPTOMS RELATED TO THE ESOPHAGEAL ULCERATION. TITLE: ¿HIGH-RESOLUTION INFRARED THERMOGRAPHY OF ESOPHAGEAL TEMPERATURE DURING RADIOFREQUENCY ABLATION OF ATRIAL FIBRILLATION.¿ THE PURPOSE OF THIS STUDY WAS TO ASSESS THE PERFORMANCE AND SAFETY OF AN INTRABODY, INFRARED ESOPHAGEAL TEMPERATURE MONITORING SYSTEM AND TO BETTER UNDERSTAND THE TYPICAL THERMAL PATTERNS THAT OCCUR DURING A STANDARD-OF-CARE, FIRST-TIME PULMONARY VEIN ISOLATION USING RADIOFREQUENCY ABLATION ENABLED BY A STATE-OF-THE-ART CARDIAC MAPPING AND NAVIGATION SYSTEM. 16 PATIENTS WERE ENROLLED IN THIS STUDY. THERMOCOOL SF RF ABLATION CATHETERS WERE USED IN THIS STUDY, HOWEVER CATALOG AND LOT NUMBER WERE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227225 TCOOL SF CARTO XP UNI, TC, F CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other| R