BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3131858 · Received May 29, 2013

    Report

    Report Number
    9673241-2013-00171
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    AFTER MULTIPLE ATTEMPTS TO RETRIEVE THE DEVICE, THE PRODUCT WAS NOT RETURNED FOR BWI INVESTIGATION AS INITIALLY REPORTED. DEVICE HISTORY RECORDS 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. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FLUTTER LEFT PROCEDURE (L-AFL), AFTER PLUGGING THE THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER IN, THERE WAS NOISE ON THE BS AND IC ELECTROGRAMS. BY CHANGING OUT THE CATHETER CABLE DID NOT RESOLVE THE ISSUE. FOLLOW UP WAS PERFORMED TO OBTAIN DETAILED INFORMATION REGARDING THE EVENT AND IT WAS CONFIRMED THAT THE NOISE OCCURRED ON BOTH CARTO AND THE RECORDING SYSTEM AT THE SAME TIME. DUE TO THIS FACT, THE PHYSICIAN WAS NOT ABLE TO INTERPRET BS AND IC SIGNALS MAKING THIS EVENT REPORTABLE. THE PROCEDURE WAS COMPLETED BY REPLACING THE CATHETER WITHOUT PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235819 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1313-04-S 15729379L

    Patients

    Seq Age Sex Outcome Treatment
    1