BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 2963783 · Received February 15, 2013

    Report

    Report Number
    9673241-2013-00043
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS HAVE BEEN MADE TO REQUEST FOR THE COMPLAINT PRODUCT TO BE RETURNED FOR ANALYSIS. PRODUCT WAS NOT RETURNED FOR INVESTIGATION AS INITIALLY REPORTED. THE DEVICE HISTORY RECORD WAS REVIEWED, AND WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE END OF AN ATRIAL FIBRILLATION (AFIB) PROCEDURE UPON REMOVAL OF THE CATHETER CHAR WAS NOTED ON THE TIP. THE PHYSICIAN WIPED OFF THE CHAR FROM THE CATHETER TIP. THE CATHETER FLUSHED AS EXPECTED PRIOR TO USING IT ON THE PATIENT, THE GENERATOR AND THE PUMP FUNCTIONED PROPERLY. NO PATIENT CONSEQUENCE WAS REPORTED. THE MAXIMUM POWER SET WAS 30 WATT AND FLOW RATE WAS AT 8CC/MIN. MULTIPLE ATTEMPTS HAVE BEEN MADE TO REQUEST FOR THE DESCRIPTION OR APPROXIMATE SIZE OF THE CHAR. HOWEVER, NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68763 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1317-05-S 15759336L

    Patients

    Seq Age Sex Outcome Treatment
    1