BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 6368694 · Received March 1, 2017

    Report

    Report Number
    9673241-2017-00168
    Event Type
    Injury
    Date Received
    March 1, 2017
    Date of Event
    May 30, 2016
    Report Date
    February 3, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    NI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. OTHER COMPANIES¿ DEVICE WERE USED IN THIS STUDY: DWI-MRI ((B)(4)); ENSITE NAVX ((B)(4)). (B)(4). THE DEVICE IS NOT RETURNED TO BWI.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT 18 PATIENTS SCHEDULED FOR VENTRICULAR TACHYCARDIA AND PREMATURE VENTRICULAR COMPLEXES ABLATION BETWEEN NOVEMBER 2014 AND MAY 2016 WERE INCLUDED IN THE STUDY. AMONG THEM, 16 NEW CEREBRAL EMBOLI WERE IDENTIFIED IN 7 PATIENTS IN THE LV ABLATION GROUP. NONE OF THE PATIENTS WAS SYMPTOMATIC AND NONE OF THE PRE OR POST PHYSICAL EXAMINATIONS REVEALED ANY NEW NEUROLOGIC DEFICITS. THOSE WITH CEREBRAL EMBOLI ALL UNDERWENT RETROGRADE AORTIC APPROACHES. 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: ¿BRAIN EMBOLI AFTER LEFT VENTRICULAR ENDOCARDIAL ABLATION.¿ THE PURPOSE OF THIS STUDY WAS TO DETERMINE WHETHER CEREBRAL EMBOLI IDENTIFIED BY COMPARING PRE- AND POSTPROCEDURAL DIFFUSION-WEIGHTED MAGNETIC RESONANCE IMAGING (DWI-MRI) OF THE BRAIN OCCUR AFTER LEFT VENTRICLE ENDOCARDIAL ABLATION. SUSPECT DEVICE IS SMARTTOUCH THERMOCOOL ABLATION CATHETER, HOWEVER CATALOG AND LOT NUMBER ARE UNKNOWN. OTHER COMPANIES¿ DEVICE WERE USED IN THIS STUDY: DWI-MRI ((B)(4)); ENSITE NAVX ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151074 THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-00 UNKNOWN_D-1336-00

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening