BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 3821876 · Received May 20, 2014

    Report

    Report Number
    9673241-2014-00200
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    February 25, 2014
    Report Date
    February 26, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT DURING THE VENTRICULAR TACHYCARDIA (VT) PROCEDURE, THE SMART TOUCH UNIDIRECTIONAL CATHETER DEFLECTION DID NOT RESPOND WHILE IN THE LEFT VENTRICLE (LV). THE CATHETER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND THE TIP DOME WAS FOUND WITH CHAR. THIS CONDITION WAS NOT REPORTED BY THE CUSTOMER. 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 THE CATHETER PASSED. THEN PER THE REPORTED EVENT, THE CATHETER WAS TESTED FOR DEFLECTION AND THE CATHETER FAILED. AFTERWARDS, THE CATHETER WAS DISSECTED AND IT WAS NOTICED THAT THE T BAR SLID DOWN FROM ITS PLACE. 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 REPORTED CUSTOMER COMPLAINT HAS BEEN VERIFIED. THE ROOT CAUSE OF THE CHAR REMAINS UNKNOWN. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THE T BAR ISSUE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION STILL IN PROGRESS. A SUPPLEMENTAL REPORT OR DEVICE EVALUATION WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE VENTRICULAR TACHYCARDIA (VT) PROCEDURE, THE SMART TOUCH UNIDIRECTIONAL CATHETER DEFLECTION DID NOT RESPOND WHILE IN THE LEFT VENTRICLE (LV). THE CATHETER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED. THE COMPLAINT REPORTED WAS NOT INDICATIVE OF A REPORTABLE EVENT. UPON VISUAL INSPECTION OF THE RETURNED COMPLAINT CATHETER ON APRIL 29, 2014, THE BWI FAILURE ANALYSIS LAB NOTED THAT THE TIP DOME HAD CHAR THAT MEASURED MORE THAN 1 MM. THIS CONDITION WAS NOT REPORTED BY THE CUSTOMER. THE AMOUNT OF CHAR FOUND IS INDICATIVE OF A REPORTABLE EVENT, THUS MARKING APRIL 29, 2014 AS THE AWARENESS DATE FOR THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300315 THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-01-S 16012600M

    Patients

    Seq Age Sex Outcome Treatment
    1