BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 3954088 · Received July 23, 2014

    Report

    Report Number
    2029046-2014-00206
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT ON DEVICE EVALUATION WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT HIGH SPI ERROR (ERROR 88) MESSAGE WAS DISPLAYED DURING ABLATION. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND BLOOD SIMILAR TO CHAR WAS FOUND AT THE END OF THE TIP. THIS CONDITION WAS NOT REPORTED BY THE CUSTOMER. THEN PER THE REPORTED EVENT, THE CATHETER WAS EVALUATED FOR CARTO 3 AND SCREENING TEST AND CATHETER PASSED BOTH. THE CATHETER WAS RECOGNIZED BY CARTO 3 SYSTEM, NO ERROR MESSAGES WERE DISPLAYED AND THE CATHETER WAS PROPERLY VISUALIZED. NO FORCE ISSUES WERE OBSERVED. THE FORCE FEATURE WAS WORKING PROPERLY. DUE TO THE CHAR FOUND, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY AND IT 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 REPORTED CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE ROOT CAUSE OF THE CHAR REMAINS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FLUTTER RIGHT (R-AFL) PROCEDURE, HIGH SPI ERROR (ERROR 8) MESSAGE DISPLAYED DURING ABLATION. THE CABLE WAS EXCHANGED WITH NO RESOLUTION. THE ISSUE WAS RESOLVED BY EXCHANGING THE CATHETER AND THE CASE WAS COMPLETED WITHOUT ANY PATIENT CONSEQUENCE. UPON RECEIVING THE PRODUCT IN BIOSENSE WEBSTER LAB ON JUNE 27TH 2014, IT WAS NOTICED THAT CHAR ON THE PROXIMAL END OF THE TIP DOME, MAKING THIS EVENT REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430535 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1327-05-S 16083586M

    Patients

    Seq Age Sex Outcome Treatment
    1