BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART TOUCH UNIDIRECTIONAL

    MDR report key: 6870123 · Received September 15, 2017

    Report

    Report Number
    9673241-2017-01071
    Event Type
    Injury
    Date Received
    September 15, 2017
    Date of Event
    December 31, 2016
    Report Date
    August 18, 2017
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. CONCOMITANT PRODUCTS WERE USED DURING THIS STUDY: CARTO MAPPING SYSTEM. MANUFACTURER'S REF.(B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT 56 CONSECUTIVE PATIENTS WHO UNDERWENT AN ABLATION PROCEDURE FOR AF AND OR RELATED ARRHYTHMIAS FROM 2010-2016, AND IN WHOM THERE WAS EVIDENCE OF LOM-MEDIATED ARRHYTHMIAS WERE INCLUDED. AMONG THEM, DESPITE DEEP SEDATION, 2 PATIENTS EXPERIENCED FLEETING CHEST DISCOMFORT WITH ETOH INFUSION, WITHOUT CHANGES IN THE ELECTROCARDIOGRAM. 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: ¿SPECTRUM OF ATRIAL ARRHYTHMIAS UTILIZING THE LIGAMENT OF MARSHALL IN PATIENTS WITH ATRIAL FIBRILLATION¿ THE PURPOSE OF THIS STUDY WAS TO DESCRIBE THE ROLE OF THE LOM IN A SERIES OF PATIENTS UNDERGOING CATHETER ABLATION OF AF OR POST-ABLATION ATRIAL TACHYCARDIA (AT). SUSPECT DEVICE IS A 3.5 MM TIP IRRIGATED RADIOFREQUENCY CATHETER THERMOCOOL, HOWEVER CATALOG AND LOT NUMBER IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648655 SMART TOUCH UNIDIRECTIONAL CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other