BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 5691723 · Received June 1, 2016

    Report

    Report Number
    9673241-2016-00360
    Event Type
    Injury
    Date Received
    June 1, 2016
    Date of Event
    April 18, 2016
    Report Date
    April 22, 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 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 17416399M HAS BEEN REVIEWED AND IT WAS VERIFIED THAT DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. (B)(4). THE DEVICE WAS NOT RETURNED TO BWI.

    Description of Event or Problem · 1

    THIS EVENT IS PART OF (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT ONE (B)(6) MALE PATIENT WITH MEDICAL HISTORY OF SYMPTOMATIC ATRIAL FIBRILLATION UNDERWENT PULMONARY VEIN ISOLATION PROCEDURE USING SMART TOUCH CATHETER (CATALOG # D132705, LOT # 17416399M). THE PATIENT HAD PERICARDIAL IRRITATION(WITHOUT EFFUSION) WHICH REQUIRED MEDICATION. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS NOT DEVICE RELATED AND POSSIBLY PROCEDURE RELATED. IT WAS ALSO REPORTED THAT DURING THE SAME PROCEDURE SMART TOUCH CATHETER (CATALOG # D132705, LOT # 17416363M) AND SMART TOUCH CATHETER (CATALOG # D132705, LOT # 17410937M) BOTH USED DURING THIS CASE. IT WAS ALSO REPORTED THAT OTHER MDR NOT REPORTABLE PRODUCT ISSUES OCCURRED DURING THE SAME PROCEDURE. SMART TOUCH CATHETER (CATALOG # D132705, LOT # 17416399M) HAD SIGNAL INTERFERENCE (NOISE) ON IC ONLY ON BOTH CARTO AND RECORDING SYSTEM. THE PHYSICIAN HAD AT LEAST ONE ECG SIGNAL AVAILABLE TO MONITOR PATIENT HEART RHYTHM. IT WAS ALSO REPORTED THAT DURING THE SAME PROCEDURE SMART TOUCH CATHETER (CATALOG # D132705, LOT # 17416363M) AND SMART TOUCH CATHETER (CATALOG # D132705, LOT # 17410937M) BOTH HAD ERROR 19 AND 8 (PIU E661 CARD BIT ERROR). THE CARTO SYSTEM WAS BLOCKED WHEN TAKING THE BACK-UP AND WAS MANUALLY SHUT DOWN POST USE. THE PACING LEADS WERE CONNECTED TO CARTO 3 PIU PRIMARY PACING PORT, AND CARTO WAS FUNCTION WELL (DID NOT ALLOW PACING AND ABLATING AT THE SAME TIME). MICROPACE PACING STIMULATOR WAS BEING USED DURING THE PROCEDURE. IT WAS A PLANNED PACING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348164 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-05-S 17416399M

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other| R