BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3232910 · Received July 18, 2013

    Report

    Report Number
    9673241-2013-00236
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROCESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA ONCE THAT THE PRODUCT ANALYSIS INVESTIGATION IS COMPLETED. MANUFACTURER REFERENCE #: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THE CHAR FORMATION ON THE TIP OF THE CATHETER. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND IN NORMAL CONDITIONS. NO CHAR WAS OBSERVED. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY AND IT WAS FOUND WITHIN SPECIFICATIONS. FURTHERMORE, A COOL FLOW PUMP TEST WAS PERFORMED AND THE CATHETER PASSED SPECIFICATIONS. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE DEVICE HISTORY RECORD (DHR) 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.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333595 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1317-05-S 15853307L

    Patients

    Seq Age Sex Outcome Treatment
    1