BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 6589701 · Received May 24, 2017

    Report

    Report Number
    9673241-2017-00403
    Event Type
    Death
    Date Received
    May 24, 2017
    Date of Event
    May 4, 2017
    Report Date
    May 4, 2017
    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 Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. 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. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM (MODEL# M-4800-01 SERIAL# (B)(4)), SMARTABLATE GENERATOR (MODEL# M-4900-07 SERIAL# (B)(4)), SMARTABLATE PUMP (MODEL# M-4900-08 SERIAL# (B)(4)), PENTARAY NAV ECO CATHETER (MODEL# D-1282-08-S LOT# 17660352L). (B)(4).

    Additional Manufacturer Narrative · 1

    THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 07/19/2017. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REF. NO: (B)(4). IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER AND A SOUNDSTAR® 3D DIAGNOSTIC ULTRASOUND CATHETER AND SUFFERED A CARDIAC TAMPONADE (REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION), CARDIAC ARREST (REQUIRING CARDIOPULMONARY RESUSCITATION), AND DEATH. THE RETURNED DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITIONS. THE CATHETER WAS EVALUATED FOR CARTO 3 FUNCTIONALITY AND IT WAS RECOGNIZED BY THE SYSTEM, NO ERROR MESSAGES WERE DISPLAYED AND THE CATHETER WAS PROPERLY VISUALIZED. EEPROM DATA DEMONSTRATES THE CATHETER WAS PROPERLY CALIBRATED DURING MANUFACTURING. THE CATHETER WAS EVALUATED FOR SCREENING TEST AND CATHETER PASSED. THE FORCE FEATURE WAS WORKING PROPERLY. FINALLY, THE FORCE SENSOR VALUES WERE FOUND WITHIN SPECIFICATIONS. THEN THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE AND STOCKERT COMPATIBILITY AND IT WAS FOUND WITHIN SPECIFICATIONS. ADDITIONALLY, A DEFLECTION AND AN IRRIGATION TEST WERE PERFORMED AND THE CATHETER PASSED THE TESTS. 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, CARDIAC ARREST AND DEATH 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 FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER AND A SOUNDSTAR® 3D DIAGNOSTIC ULTRASOUND CATHETER AND SUFFERED A CARDIAC TAMPONADE (REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION), CARDIAC ARREST (REQUIRING CARDIOPULMONARY RESUSCITATION), AND DEATH. DURING THE PROCEDURE, A TAMPONADE WAS CONFIRMED VIA ULTRASOUND. INITIAL PERICARDIOCENTESIS YIELDED 660ML OF FLUID. PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND WAS SCHEDULED TO BE TRANSFERRED TO THE CORONARY CARE UNIT FOR OBSERVATION. A LATER REPORT INDICATED THAT 2500ML WAS DRAINED. THORACOTOMY REVEALED A PERFORATION IN THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) AND RIGHT VENTRICULAR TRAUMA SECONDARY TO CHEST COMPRESSIONS. INTRACARDIAC ECHOCARDIOGRAM (ICE) CATHETER WAS IN THE PATIENT¿S HEART WHILE MONITORING THE TAMPONADE AND REMAINED THERE DURING CHEST COMPRESSIONS. IT WAS NOTED THAT THE ICE (SOUNDSTAR) CATHETER MAY HAVE CONTRIBUTED TO THE INJURIES. MEDICAL HISTORY INCLUDED STEROID MEDICATION THAT IMPAIRED THE INTEGRITY OF THE CARDIAC TISSUE, WHICH MADE IT IMPOSSIBLE FOR THE SURGEON TO REPAIR THE PERFORATION. PATIENT EXPIRED DURING THE SURGICAL INTERVENTION. PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION REGARDING THE ADVERSE EVENT OR THE DEATH EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367961 THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-03-S 17632395M 10846835009019

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R