BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 4110086 · Received September 23, 2014

    Report

    Report Number
    2029046-2014-00309
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S025
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. AS LOT # 17050794L WAS PROVIDED, THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. CONCOMITANT BWI PRODUCT USED: PRODUCT NAME:CARTO® 3 SYSTEM: US CATALOG #: FG540000, SERIAL #: (B)(4). PRODUCT NAME: SMART TOUCH BIDIRECTIONAL: US CATALOG #: D132705, LOT #: 17005150M. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER, AND THERE WAS NOISE ON ALL ELECTROCARDIOGRAM SIGNALS AS ALSO NO IMPEDANCE WAS DISPLAYING; THEREFORE, THE PROCEDURE GOT CANCELLED. THERE WAS NO PATIENT CONSEQUENCE. PER 21 CFR, PART 803, THIS COMPLAINT IS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589257 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1313-05-S UNKNOWN_D-1313-05-S

    Patients

    Seq Age Sex Outcome Treatment
    1