BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 4141234 · Received October 3, 2014

    Report

    Report Number
    2029046-2014-00351
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 7, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S025
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS LOT #17010835L WAS PROVIDED, THE DEVICE HISTORY RECORD(S) 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). IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. (B)(4). THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND CHAR WAS FOUND ON THE TIP DOME. THIS CONDITION WAS NOT REPORTED BY THE CUSTOMER. THEN PER THE REPORTED EVENT, A DEFLECTION TEST WAS PERFORMED AND CATHETER PASSED. 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 CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE ROOT CAUSE OF THE CHAR REMAINS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, UNDERWENT A LEFT ATRIAL FLUTTER PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND A DEFLECTION ISSUE OCCURRED. THERE WAS NO PATIENT CONSEQUENCE. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, PRODUCT RETURNED ON SEPTEMBER 12TH 2014 AND HAVE REASSESSED THE EVENT AS REPORTABLE. FAILURE ANALYSIS LABORATORY RECEIVED THE DEVICE FOR EVALUATION AND FOUND CHAR ON THE DISTAL END TIP ELECTRODE WHICH MEASURED ABOUT 2 MM. THIS FINDING IS REPORTABLE BECAUSE THIS COULD POTENTIALLY CONTRIBUTE TO A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620346 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1317-05-S 17010835L

    Patients

    Seq Age Sex Outcome Treatment
    1