BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 4090782 · Received September 15, 2014

    Report

    Report Number
    2029046-2014-00299
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 5, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AND THE COMPLAINT (IRRIGATION ISSUE AND HIGH TEMPERATURE ISSUE) WAS NOT CONFIRMED AT THIS TIME. ONCE THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT THE CATHETER WAS NOT IRRIGATING ON ALL PORTS BEFORE INSERTION AND WAS RESOLVED BY FLUSHING. IT WAS ALSO REPORTED THAT A HIGH TEMPERATURE READING OF 30-45 WAS OBSERVED AND DURING ABLATION A TEMPERATURE LIMITER WAS DISPLAYED ON THE STOCKERT GENERATOR. THERE WAS MINIMAL FLOW WHEN THE CATHETER WAS REMOVED FROM THE PATIENT AND THERE WAS CHAR ON THE TIP OF THE CATHETER AS WELL. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND CHAR WAS FOUND ON CATHETER DOME. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY AND IT WAS FOUND WITHIN SPECIFICATIONS. FURTHERMORE, 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 REGARDING THE CHAR HAS BEEN VERIFIED. HOWEVER, CATHETER MET THE MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE CATHETER WAS NOT IRRIGATING ON ALL PORTS BEFORE INSERTION AND WAS RESOLVED BY FLUSHING. IT WAS ALSO REPORTED THAT THEY WERE GETTING A HIGH TEMPERATURE READING OF 30-45 WHEN THEY CAME ON ABLATION AND TEMPERATURE LIMITER DISPLAYED ON THE STOCKERT GENERATOR AND THEN IT SHUT OFF. THE CUSTOMER REPORTED THAT THERE WAS A MINIMAL FLOW WHEN THE CATHETER WAS REMOVED FROM THE PATIENT AND THERE WAS CHAR ON THE TIP OF THE CATHETER. THE CATHETER WAS EXCHANGED AND THE CASE WAS COMPLETED WITHOUT ANY PATIENT CONSEQUENCE. MULTIPLE ATTEMPTS WERE DONE TO REQUEST FOR FURTHER DETAILS OF THE SIZE OF CHAR. HOWEVER NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. UPON RECEIVING THE PRODUCT IN BIOSENSE (B)(4) LAB ON (B)(4) 2014, IT WAS CONFIRMED THAT THE TIP DOME HAD CHAR BIGGER THAT 1 MM3 ON THE PROXIMAL END, MAKING THIS EVENT REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568759 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1327-04-S 17004513M

    Patients

    Seq Age Sex Outcome Treatment
    1