BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 5991670 · Received September 30, 2016

    Report

    Report Number
    9673241-2016-00636
    Event Type
    Death
    Date Received
    September 30, 2016
    Date of Event
    January 31, 2015
    Report Date
    September 7, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. CONCOMITANT PRODUCTS WERE USED DURING THIS STUDY: CARTO 3 SYSTEM; PENTARAY NAV; 64-ELEMENT, 5.5¿10.0 MHZ, SOUNDSTAR; DECANAV; NAVISTAR, NAVISTAR THERMOCOOL, THERMOCOOL SF. METHODS: NO TESTING METHODS PERFORMED (B)(4). RESULTS: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED (B)(4). CONCLUSION: DEVICE DISCARDED BY USER, UNABLE TO FOLLOW-UP (B)(4). (B)(4). THE DEVICE WAS NOT RETURNED TO BWI.

    Description of Event or Problem · 1

    THIS EVENT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT ONE PATIENT EXPIRED DUE TO PULMONARY EMBOLISM. BASED ON THE FACTS OF THE CASE AND THE AUTHOR¿S ASSESSMENT, THERE WERE NO REPORTED MALFUNCTION WITH ANY OF THE BWI CATHETERS AND SYSTEMS USED DURING THE CASE. THUS, THIS EVENT IS UNRELATED TO THE DEVICE AND MOST LIKELY RELATED TO THE PROCEDURE. TITLE: EPICARDIAL RADIOFREQUENCY ABLATION FAILURE DURING ABLATION PROCEDURES FOR VENTRICULAR ARRHYTHMIAS REASONS AND IMPLICATIONS FOR OUTCOMES. THE PURPOSE OF THIS STUDY WAS TO CHARACTERIZE THE REASONS FOR EPICARDIAL ABLATION FAILURE AFTER SUCCESSFUL EPICARDIAL ACCESS, TO RELATE THESE TO THE TARGETED EPICARDIAL AREA, AND TO ASSESS IMPLICATIONS OF FAILED OR LIMITED EPICARDIAL RFA ON OUTCOME FOR VA ABLATION PROCEDURES. THE STUDY WAS CONDUCTED BETWEEN JANUARY 1999 AND JANUARY 2015. SUSPECTED DEVICE IS THE IRRIGATED THERMOCOOL SMART-TOUCH, HOWEVER CATALOG AND LOT NUMBER ARE UNKNOWN. SHOULD MORE INFORMATION BE RECEIVED, PRODUCT FOR THIS ADVERSE EVENT WILL BE MODIFIED AS APPROPRIATE. CONCOMITANT PRODUCTS WERE USED DURING THIS STUDY: CARTO 3 SYSTEM; PENTARAY NAV; 64-ELEMENT, 5.5¿10.0 MHZ, SOUNDSTAR; DECANAV; NAVISTAR, NAVISTAR THERMOCOOL, THERMOCOOL SF. THE AWARENESS DATE FOR THIS COMPLAINT IS 9/06/2016 BECAUSE THE ARTICLE WAS REVIEWED ON 09/6/2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641628 THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-00 UNKNOWN_D-1336-00

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death