BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3172684 · Received June 17, 2013

    Report

    Report Number
    9673241-2013-00192
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S025
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) PRIOR TO THE PROCEDURE, IT WAS OBSERVED ALL OF THE SIGNALS INCLUDING ECGS, DIAGNOSTIC CATHETERS (HRA, CS, RV) SIGNALS WERE SEVERELY NOISED AND PHYSICIAN WAS NOT ABLE TO RECOGNIZE ANY OF THE SIGNALS. THE UNIT WAS REBOOTED AND ABLATION CABLES WERE REPLACED HOWEVER THE ISSUE PERSISTED. ISSUE WAS RESOLVED AFTER THE ABLATION CATHETER WAS REPLACED. ADDITIONAL INFORMATION PROVIDED STATED THE SIGNAL NOISE OCCUR ON BOTH CARTO AND THE RECORDING SYSTEM AT THE SAME TIME. THE SIGNAL NOISE ISSUE OCCURRED AFTER THE ABLATION CATHETER WAS CONNECTED. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND IN NORMAL CONDITIONS. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE AND IT WAS FOUND WITHIN SPECIFICATIONS. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS FAILURE MODE. DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    PRIOR TO THE PROCEDURE, IT WAS OBSERVED ALL OF THE SIGNALS INCLUDING ECGS, DIAGNOSTIC CATHETERS (HRA, CS, RV) SIGNALS WERE SEVERELY NOISED AND PHYSICIAN WAS NOT ABLE TO RECOGNIZE ANY OF THE SIGNALS. THE UNIT WAS REBOOTED AND ABLATION CABLES WERE REPLACED HOWEVER THE ISSUE PERSISTED. ISSUE WAS RESOLVED AFTER THE ABLATION CATHETER WAS REPLACED. ADDITIONAL INFORMATION PROVIDED STATED THE SIGNAL NOISE OCCUR ON BOTH CARTO AND THE RECORDING SYSTEM AT THE SAME TIME. THE SIGNAL NOISE ISSUE OCCURRED AFTER THE ABLATION CATHETER WAS CONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273373 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1313-05-S 15838397L

    Patients

    Seq Age Sex Outcome Treatment
    1