BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 5954989 · Received September 15, 2016

    Report

    Report Number
    9673241-2016-00604
    Event Type
    Injury
    Date Received
    September 15, 2016
    Date of Event
    September 30, 2013
    Report Date
    August 19, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. SINCE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER CANNOT BE PROVIDED. CONCOMITANT PRODUCTS WERE USED DURING THIS STUDY: CARTO. (B)(4). THE DEVICE WAS NOT RETURNED TO BWI.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT 1 PATIENT WITH PAROXYSMAL ATRIAL FIBRILLATION UNDERWENT RADIOFREQUENCY ABLATION AND SUFFERED HAEMOPTYSIS. 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: "OUTCOMES AFTER CRYOABLATION VS. RADIOFREQUENCY IN PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION: IMPACT OF PULMONARY VEINS ANATOMY." THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE MID-TERM OUTCOMES OF CRYOBALLOON ABLATION IN AN UNSELECTED POPULATION WITH PAROXYSMAL AF FROM AN ANATOMICAL VIEWPOINT. THE STUDY WAS CONDUCTED FROM SEPTEMBER 2010 TO SEPTEMBER 2013. 376 PATIENTS WERE ENROLLED IN RADIOFREQUENCY GROUP. THERMOCOOL SMARTTOUCH AND TACTICATH ABLATION CATHETERS WERE USED IN RADIOFREQUENCY GROUP. BWI TAKES CONSERVATIVE APPROACH TO OPEN THIS COMPLAINT UNDER THERMOCOOL SMARTTOUCH ABLATION CATHETER, 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: LASSO CATHETER, CARTO SYSTEM OTHER COMPANY'S DEVICES WERE USED DURING THIS STUDY: ARCTIC FRONT CRYOBALLOON CATHETER (MEDTRONIC), ARCTIC FRONT ADVANCE (MEDTRONIC), VELOCITY SYSTEM (ST JUDE MEDICAL), TACTICATH (ENDOSENSE, (B)(4)). THE AWARENESS DATE FOR THIS COMPLAINT IS 8/19/2016 BECAUSE THE ARTICLE WAS REVIEWED ON 8/19/2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603397 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-05-S UNK_D-1327-05-S

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other