BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 6119519 · Received November 21, 2016

    Report

    Report Number
    9673241-2016-00812
    Event Type
    Injury
    Date Received
    November 21, 2016
    Date of Event
    October 27, 2016
    Report Date
    October 27, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    UDI-DI
    10846835009019
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCT: LASSO NAV VARIABLE ECO (MODEL#: D-1343-01-S LOT #: 17497532L). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A MALE PATIENT, OVER 60 YEARS OLD, UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE, WHICH REQUIRED PERICARDIOCENTESIS. THE RETURNED DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITIONS. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND GENERATOR TEST AND IT WAS FOUND WITHIN SPECIFICATIONS. A DEFLECTION TEST WAS PERFORMED AND THE CATHETER PASSED. THE CATHETER WAS EVALUATED FOR EEPROM, AND THE FUNCTIONALITY OF THE SENSORS OF THE CATHETER WERE TESTED ON CARTO 3 SYSTEM. THE CATHETER WAS RECOGNIZED BY CARTO 3 SYSTEM, NO ERROR MESSAGES WERE DISPLAYED AND THE CATHETER WAS PROPERLY VISUALIZED. EEPROM DATA DEMONSTRATES THE CATHETER WAS PROPERLY CALIBRATED DURING MANUFACTURING. THE FORCE FEATURES WAS EVALUATED AND PASSED. FINALLY, AN IRRIGATION TEST WAS PERFORMED AND THE CATHETER PASSED, NO OCCLUSION WAS OBSERVED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE CARDIAC TAMPONADE REMAINS UNKNOWN. THE INSTRUCTIONS FOR USE STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT, OVER (B)(6), UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE, WHICH REQUIRED PERICARDIOCENTESIS. WHILE MAPPING, SOMETIME BETWEEN TRANSSEPTAL AND ABLATION, A PERICARDIAL EFFUSION WAS NOTICED AS THE PATIENT'S BLOOD PRESSURE DROPPED. NO ABLATIONS WERE PERFORMED. THE PERICARDIAL EFFUSION WAS CONFIRMED BY ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS PERFORMED AND 1500CC OF FLUID WAS REMOVED. POST PROCEDURE THE PATIENT WAS STABLE AND TRANSFERRED TO THE INTENSIVE CARE UNIT FOR OBSERVATION (ICU). THE PATIENT WAS MONITORED IN THE ICU OVERNIGHT AND REQUIRED ADDITIONAL DAYS IN THE TELEMETRY UNIT POST-ICU. THE PATIENT¿S CONDITION HAS SINCE IMPROVED. THE PHYSICIAN WAS UNSURE EXACTLY WHEN THE EFFUSION OCCURRED. HOWEVER, BELIEVES IT HAPPENED DURING THE TRANSSEPTAL PUNCTURE. THERE WAS NO PRODUCT MALFUNCTION. A TRANSSEPTAL PUNCTURE WAS DONE WITH A BAYLIS NEEDLE. A ST JUDE MEDICAL SL1 SHEATH WAS USED DURING THE PROCEDURE. THE PATIENT RECEIVED ANTICOAGULANT DURING THE PROCEDURE, HOWEVER THE ACTIVATED CLOTTING TIME IS UNKNOWN. IRRIGATION FLOW WAS SET TO 2ML/MIN DURING MAPPING PHASE. THERE ARE NO KNOWN PATIENT FACTORS THAT MIGHT HAVE CONTRIBUTED TO THE EVENT. THERE WERE NO REPORTED ERROR MESSAGES ON BIOSENSE WEBSTER INC EQUIPMENT DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768832 THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-03-S 17469789M 10846835009019

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R