BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 5792893 · Received July 13, 2016

    Report

    Report Number
    9673241-2016-00432
    Event Type
    Malfunction
    Date Received
    July 13, 2016
    Date of Event
    April 5, 2016
    Report Date
    April 7, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    UDI-DI
    10846835009200
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A SMART TOUCH BIDIRECTIONAL CATHETER. THERE WAS A DISCONNECTED MAGNETIC SENSOR ERROR MESSAGE. THEY CHANGED THE CABLE. HOWEVER, THIS DID NOT RESOLVE THE ISSUE. THE PROBLEM WAS RESOLVED BY REPLACING THE CATHETER. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. THE RETURNED DEVICE WAS VISUALLY INSPECTED AND A WHITISH FIBROUS FOREIGN MATERIAL WAS OBSERVED AT CATHETER TIP DOME. A FOURIER TRANSFORM INFRARED SPECTROSCOPY (FT-IR) IN ORDER TO IDENTIFY THE TYPE OF FOREIGN MATERIAL; THE RESULTS DEMONSTRATED THAT THE MATERIAL HAD A BIOLOGICAL COMPOSITION SIMILAR TO THE SHOWED BY HUMAN TISSUE. FURTHER INFORMATION RECEIVED INDICATES THAT THERE WAS NO RESISTANCE NOTICED WHILE INTRODUCING OR WITHDRAWING THE CATHETER. THE CATHETER OUTER DIAMETERS WERE MEASURED AND THEY WERE FOUND WITHIN SPECIFICATIONS. THERE WERE NO SHARP EDGES OR EXPOSED PARTS OBSERVED. THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE AND IT WAS FOUND WITHIN SPECIFICATIONS. THE CATHETER SENSOR FUNCTIONALITY WAS TESTED ON CARTO. THE CATHETER FAILED DURING THE CARTO TEST ERROR 105 WAS DISPLAYED. FURTHER EXAMINATION SHOWED THAT THE SENSOR WAS WITHIN SPECIFICATIONS. ACCORDING TO THE CALIBRATION RESULTS AND THE SENSOR READINGS, THE IMPROPER CONDITION WAS ATTRIBUTED TO A POTENTIAL PC BOARD FAILURE. 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 HAS BEEN VERIFIED. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO INVESTIGATE THE POTENTIAL PCB ISSUES/INTERMITTENCY. BASED ON AVAILABLE ANALYSIS FINDING RESULTS, THE ROOT CAUSE OF THE FOREIGN PARTICLE FOUND DOES NOT APPEAR TO BE CAUSED BY ANY INTERNAL BIOSENSE WEBSTER, INC. PROCESSES SINCE THE CATHETER PHYSICAL CONDITION WAS FOUND WITHIN SPECIFICATIONS.

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A SMART TOUCH BIDIRECTIONAL CATHETER. INITIALLY, THERE WAS A DISCONNECTED MAGNETIC SENSOR ERROR MESSAGE. THEY CHANGED THE CABLE. HOWEVER, THIS DID NOT RESOLVE THE ISSUE. THE PROBLEM WAS RESOLVED BY REPLACING THE CATHETER. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. THIS ISSUE IS EASILY DETECTABLE BY THE USER. THE CATHETER IS INOPERABLE , SINCE IT CANNOT BE VISUALIZED ON THE CARTO SYSTEM. THE USER WILL HAVE TO REPLACE THE CATHETER. THE MOST LIKELY CONSEQUENCE IS AN INTRAPROCEDURAL DELAY . THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH IS REMOTE. THE BIOSENSE WEBSTER FAILURE ANALYSIS LAB RECEIVED THE CATHETER AND DISCOVERED ON (B)(6) 2016 LIGHT BROWN MATERIAL WITH SOME WHITE FIBROUS MATERIAL MEASURING ABOUT 6MM DOWN FROM THE SIDE OF TIP DOME. THE FOREIGN MATERIAL FOUND ADHERED TO THE CATHETER WITHIN THE USABLE LENGTH DURING THE PROCEDURE MAY POSE A POTENTIAL PATIENT RISK AND THEREFORE HAS BEEN ASSESSED AS A REPORTABLE MALFUNCTION. THE AWARENESS DATE HAS BEEN RESET TO (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443115 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-05-S 17340180M 10846835009200

    Patients

    Seq Age Sex Outcome Treatment
    1