BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 4243398 · Received November 11, 2014

    Report

    Report Number
    9673241-2014-00478
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 17, 2014
    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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON NOVEMBER 18, 2014. 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 A PROCEDURE WITH A THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER AND CHAR WAS FOUND. THERE WAS NO PATIENT CONSEQUENCE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO IRRIGATION OR TEMPERATURE ISSUES WERE NOTED DURING THE CASE. AFTER PROCEDURE, THE PHYSICIAN NOTICED CHAR AT THE TIP OF THE CATHETER. THE PHYSICIAN CONSIDERED THAT THE CHAR WAS EXCESSIVE. SETTINGS DURING THE EVENT INCLUDE: ABLATION BETWEEN 20 W AND 30 W, FLOW RATE AT 8 ML/MIN AND ACT WAS AT > 300 S. HEPARIN WAS USED, 1000 I.E PER LITER SALINE. DUE TO THE CHAR FOUND, THIS EVENT IS DETERMINED TO BE REPORTABLE. 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. PER THE EVENT, 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 CUSTOMER COMPLAINT WAS CONFIRMED. HOWEVER, THE CATHETER MET MANUFACTURING SPECIFICATIONS. MANAGEMENT IS NOTIFIED OF FAILURE ANALYSIS RESULTS USING MONTHLY COMPLAINT TREND REPORTING. NO SIGNIFICANT TRENDS HAVE BEEN IDENTIFIED AT THIS TIME; THEREFORE NO CAPA ACTIVITY IS REQUIRED.

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. IF ADDITIONAL INFORMATION OR PRODUCT IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. AS THE LOT # 17034185L WAS PROVIDED, THE DEVICE HISTORY RECORD 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 A PATIENT UNDERWENT A PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND CHAR WAS FOUND. THERE WAS NO PATIENT CONSEQUENCE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO IRRIGATION OR TEMPERATURE ISSUES WERE NOTED DURING THE CASE. AFTER PROCEDURE, THE PHYSICIAN NOTICED CHAR AT THE TIP OF THE CATHETER. THE PHYSICIAN CONSIDERED THAT THE CHAR WAS EXCESSIVE. SETTINGS DURING THE EVENT INCLUDE: ABLATION BETWEEN 20 W AND 30 W, FLOW RATE AT 8 ML/MIN AND ACT WAS AT > 300 S. HEPARIN WAS USED, 1000 I.E PER LITER SALINE. DUE TO THE CHAR FOUND, THIS EVENT IS DETERMINED TO BE REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726193 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1317-05-S 17034185L

    Patients

    Seq Age Sex Outcome Treatment
    1