BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 6233883 · Received January 9, 2017

    Report

    Report Number
    9673241-2017-00038
    Event Type
    Death
    Date Received
    January 9, 2017
    Date of Event
    December 16, 2016
    Report Date
    December 16, 2016
    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

    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. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 17592191L HAS BEEN REVIEWED AND IT WAS VERIFIED THAT DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES.. CONCOMITANT PRODUCT: NON BIOSENSE WEBSTER, INC. - ST. JUDE MEDICAL SR0 8.5 FRENCH SHEATH. (B)(4) ARE RELATED TO THE SAME INCIDENT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 1/20/17. 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. ORIGINALLY, BIOSENSE WEBSTER, INC. REPORTED THIS EVENT UNDER BOTH THE EZ STEER THERMOCOOL SF NAVIGATIONAL CATHETER (9673241-2017-00038) AND THE SOUNDSTAR CATHETER (2029046-2017-00012). HOWEVER, ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT ON JANUARY 20, 2017 STATING THAT THE SOUNDSTAR CATHETER WAS REPROCESSED BY (B)(4) WHICH IS A DISTRIBUTED PRODUCT. THE MODEL NUMBER IS M-5723-116. THE LOT NUMBER IS UNKNOWN. THEREFORE, THIS PRODUCT IS NOT REPORTABLE UNDER BIOSENSE WEBSTER, INC. NOTIFICATION HAS BEEN PROVIDED TO (B)(4). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A MALE PATIENT IN HIS 70S UNDERWENT AN ABLATION PROCEDURE FOR ISCHEMIC VENTRICULAR TACHYCARDIA WITH AN EZ STEER THERMOCOOL SF NAVIGATIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE (REQUIRING PHARMACOLOGIC SUPPORT) WHICH RESULTED IN DEATH. DURING THE ABLATION PHASE, THE PATIENT BECAME HYPOTENSIVE AND A TAMPONADE WAS CONFIRMED VIA INTRACARDIAC ECHOCARDIOGRAM. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT AND EXPIRED THE SAME DAY. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT MAY HAVE BEEN RELATED TO THE STERILMED SOUNDSTAR CATHETER BEING IN THE RIGHT ATRIUM DURING CARDIOVERSION OF VENTRICULAR TACHYCARDIA (8 SHOCKS). 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. AFTER THAT, DEFLECTION TEST WAS PERFORMED AND THE CATHETER PASSED. THE CATHETER WAS EVALUATED FOR EEPROM, AND THE FUNCTIONALITY OF THE SENSOR OF THE CATHETER WAS TESTED ON CARTO 3 SYSTEM. THE CATHETER WAS RECOGNIZED BY THE CARTO 3 SYSTEM, NO ERROR MESSAGES WERE DISPLAYED AND THE CATHETER WAS PROPERLY VISUALIZED. EEPROM DATA DEMONSTRATES THE CATHETER WAS PROPERLY CALIBRATED DURING MANUFACTURING. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT IN HIS 70S UNDERWENT AN ABLATION PROCEDURE FOR ISCHEMIC VENTRICULAR TACHYCARDIA WITH AN EZ STEER THERMOCOOL SF NAVIGATIONAL CATHETER AND SOUNDSTAR CATHETER AND SUFFERED A CARDIAC TAMPONADE (REQUIRING PHARMACOLOGIC SUPPORT) WHICH RESULTED IN DEATH. DURING ABLATION PHASE, THE PATIENT BECAME HYPOTENSIVE AND A TAMPONADE WAS CONFIRMED VIA INTRACARDIAC ECHOCARDIOGRAM. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT AND EXPIRED THE SAME DAY. CARDIOVASCULAR MEDICAL HISTORY INCLUDES: ISCHEMIC CARDIOMYOPATHY WITH LEFT VENTRICULAR EJECTION FRACTION (LVEF) OF 15%, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), AND TOTAL OCCLUSION OF THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH STENTS IN THE LEFT CIRCUMFLEX (LCX) AND THE 1ST OBTUSE MARGINAL (OM1) CORONARY ARTERIES. THERE WERE NO OTHER FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT MAY HAVE BEEN RELATED TO THE SOUNDSTAR CATHETER BEING IN THE RIGHT ATRIUM DURING CARDIOVERSION OF VENTRICULAR TACHYCARDIA (8 SHOCKS). TRANSSEPTAL PUNCTURE WAS NOT PERFORMED, AS THE PHYSICIAN USED A RETROGRADE AORTIC APPROACH. SHEATH USED WAS A ST. JUDE MEDICAL SR0 8.5 FRENCH. GENERATOR PARAMETERS AT THE TIME OF INJURY INCLUDED POWER CONTROL MODE AT 30 WATTS (NOT TITRATED). ONE ABLATION WAS PERFORMED FOR 3 SECONDS ON THE VENTRICULAR SEPTUM. IRRIGATED CATHETER FLOW WAS SET AT 8 ML/MIN. PATIENT RECEIVED ANTICOAGULANT (HEPARIN) DURING THE PROCEDURE WITH ACTIVATED CLOTTING TIME MAINTAINED IN AN UNKNOWN RANGE. THERE WERE NO REPORTS OF SOUNDSTAR ISSUES OR MALFUNCTIONS WITH IMAGING OR MAPPING. THERE WERE NO ERRORS REPORTED ON ANY BIOSENSE WEBSTER, INC. EQUIPMENT DURING THE PROCEDURE. SINCE THIS ADVERSE EVENT RESULTED IN THE PATIENT¿S DEATH, IT IS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16864 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1313-05-S 17592191L 10846835003208

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R