BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 6093582 · Received November 10, 2016

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    Report

    Report Number
    9673241-2016-00782
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Date of Event
    August 28, 2016
    Report Date
    September 8, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    UDI-DI
    10846835009163
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. WHEN 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 A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL SMART TOUCH BIDIRECTIONAL CATHETER WHERE NOISE WAS OBSERVED ON ALL BODY SURFACE AND INTRACARDIAC SIGNALS. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT, AND REDDISH MATERIAL WAS FOUND IN THE AREA OF THE PEBAX. AS A RESULT, SCANNING ELECTRON MICROSCOPE (SEM) TESTING WAS PERFORMED OVER THE PEBAX AREA, AND IT WAS FOUND THAT THE EXTERNAL SURFACE EXHIBITED EVIDENCE OF SCRATCHES AND A PINHOLE. IT IS POSSIBLE THAT AN UNKNOWN OBJECT HIT AND SUBSEQUENTLY RUPTURED THE PEBAX. PER THE REPORTED EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE. THE CATHETER WAS FOUND WITHIN SPECIFICATION. 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 SIGNAL ISSUES HAS NOT BEEN CONFIRMED. THE PEBAX, HOWEVER, WAS FOUND TO BE DAMAGED. BASED ON THE AVAILABLE ANALYSIS RESULTS, IT CANNOT BE IDENTIFIED WHETHER THE ISSUE IS RELATED TO AN INTERNAL OR AN EXTERNAL CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL SMART TOUCH BIDIRECTIONAL CATHETER WHERE NOISE WAS OBSERVED ON ALL BODY SURFACE AND INTRACARDIAC SIGNALS. THREE HOURS AFTER THE PROCEDURE BEGAN, AFTER MAPPING AND ABLATION HAD BEEN CONDUCTED, SIGNAL NOISE WAS OBSERVED ON ALL CHANNELS. THE CATHETER CABLE WAS CHANGED, BUT THIS DID NOT RESOLVE THE ISSUE. THE CATHETER WAS THEN CHANGED, WHICH DID RESOLVE THE ISSUE. THE PROCEDURE WAS THEN COMPLETED WITHOUT ANY PATIENT CONSEQUENCE. THERE WAS A BODY SURFACE ELECTROCARDIOGRAM AVAILABLE ON A POLYGRAPH, THEREFORE THIS EVENT WAS NOT MDR REPORTABLE. UPON RECEIPT AT THE BIOSENSE WEBSTER FAILURE ANALYSIS LAB, THE RETURNED CATHETER WAS FOUND (VIA SCANNING ELECTRON MICROSCOPE ANALYSIS) TO HAVE SCRATCHES AND A PINHOLE ON THE SURFACE OF THE PEBAX, EXPOSING THE PATIENT TO THE INSIDE OF THE CATHETER. EXPOSURE TO THE INTERNAL PARTS OF THE CATHETER CAN CAUSE ISSUES SUCH AS EMBOLISM OR STROKE, MAKING THIS EVENT MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745983 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-01-S 17505061M 10846835009163

    Patients

    Seq Age Sex Outcome Treatment
    1