BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 3904685 · Received July 1, 2014

    Report

    Report Number
    9673241-2014-00239
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S034
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A THERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER AND HIGH IMPEDANCE AND CHAR WERE NOTICED ON THE DEVICE. DURING RF ABLATION, CHAR WAS NOTICED TOWARD THE END OF THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SIMILAR-LIKE DEVICE. THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION, VISUALLY INSPECTED WAS PERFORMED AND RED MATERIAL SIMILAR TO HUMAN BLOOD WAS FOUND ON THE TIP DOME. NO CHAR WAS OBSERVED. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY AND WAS FOUND WITHIN SPECIFICATIONS. IN ADDITION, AN IRRIGATION TEST WAS PERFORMED AND CATHETER PASSED, NO OCCLUSION WAS OBSERVED. 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. THE CUSTOMER COMPLAINT WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATING PROCEDURE WITH A THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER AND HIGH IMPEDANCE AND CHAR WERE NOTICED ON THE DEVICE. DURING RF ABLATION, CHAR WAS NOTICED TOWARD THE END OF THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SIMILAR-LIKE DEVICE. SETTINGS DURING THE EVENT INCLUDE: IMPEDANCE CUT-OFF AT 250 OHMS, IN POWER CONTROL MODE AT 30 WATTS AND 8 CC/MIN OF FLOW RATE. THIS EVENT IS BEING REPORTED DUE TO THE POTENTIAL RISK OF THE CHAR FOUND TO THE PATIENT. THE AWARENESS DATE WAS UPDATED FOR THIS RECORD BECAUSE MORE INFORMATION BECAME AVAILABLE TO BWI ON JUNE 12TH, 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383201 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1315-04-S 16064837L

    Patients

    Seq Age Sex Outcome Treatment
    1