BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 6617912 · Received June 7, 2017

    Report

    Report Number
    9673241-2017-00440
    Event Type
    Death
    Date Received
    June 7, 2017
    Date of Event
    May 11, 2017
    Report Date
    May 11, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    UDI-DI
    10846835003208
    PMA / PMN Number
    P030031/S025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 PRODUCTS: CARTO 3 SYSTEM (MODEL# M-4800-01 SERIAL# (B)(4)). SMARTABLATE GENERATOR. SMARTABLATE PUMP. EZ STEER CORONARY SINUS CATHETER (MODEL# D-1263-05-S LOT# 17639993M). LASSO NAV VARIABLE ECO CATHETER (MODEL# D-1343-01-S LOT#17649146L). (B)(4).

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REFERENCE NUMBER: (B)(4). IT WAS REPORTED THAT AN (B)(6) MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED A CARDIAC ARREST (REQUIRING CARDIOPULMONARY RESUSCITATION AND PHARMACOLOGIC SUPPORT), THROMBOSIS (REQUIRING TISSUE PLASMINOGEN ACTIVATOR), AND DEATH. THE RETURNED DEVICE WAS VISUALLY INSPECTED, AND WAS FOUND IN GOOD CONDITION. THE CATHETER WAS EVALUATED FOR CARTO 3 SYSTEM PERFORMANCE, AND WAS RECOGNIZED BY THE SYSTEM WITH NO ERROR MESSAGES AND PROPER VISUALIZATION. EEPROM DATA DEMONSTRATES THAT THE CATHETER WAS PROPERLY CALIBRATED DURING MANUFACTURING. THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE AND STOCKERT COMPATIBILITY, AND WAS FOUND WITHIN SPECIFICATIONS. DEFLECTION AND IRRIGATION TESTS WERE PERFORMED, WHICH THE CATHETER PASSED. 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 CAUSES OF THE CARDIAC ARREST, THROMBOSIS AND DEATH REMAIN UNKNOWN. THE INSTRUCTIONS FOR USE STATE 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 AN (B)(6) MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED A CARDIAC ARREST (REQUIRING CARDIOPULMONARY RESUSCITATION AND PHARMACOLOGIC SUPPORT), THROMBOSIS (REQUIRING TISSUE PLASMINOGEN ACTIVATOR), AND DEATH. DURING THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE AND HYPOXIC. POST-ABLATION, THE PATIENT WAS CARDIOVERTED. PATIENT ARRESTED AND CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED. PATIENT WAS PREPARED FOR A CARDIAC CATHETERIZATION. SINCE THERE MAY HAVE BEEN A POSSIBLE EMBOLIC EVENT, TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS ADMINISTERED. IT WAS NOTED THAT MYOCARDIAL STUNNING MAY HAVE OCCURRED. INTRACARDIAC ULTRASOUND AND TRANSTHORACIC ECHOCARDIOGRAM REVEALED NO PERICARDIAL EFFUSION. INITIALLY, THE PATIENT WAS REPORTED TO BE IN UNSTABLE CONDITION. PATIENT REQUIRED EXTENDED HOSPITALIZATION IN THE INTENSIVE CARE UNIT AS A RESULT OF THE ADVERSE EVENT FOR STABILIZATION AND MONITORING. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE EVENT IS THAT IT WAS POSSIBLY RELATED TO POST-ABLATION CARDIOVERSION. INJURIES HAVE NOT BEEN CONFIRMED. ADDITIONAL INFORMATION WAS LATER RECEIVED THAT THE PATIENT EXPIRED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF DEATH IS THAT IT WAS RELATED TO AN EMBOLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400591 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1313-05-S 17636723L 10846835003208

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| H| R