BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 3881253 · Received June 18, 2014

    Report

    Report Number
    9673241-2014-00224
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    March 18, 2014
    Report Date
    April 3, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT THE STEERING MECHANISM OF THE CATHETER FAILED AND THE CATHETER WAS NOT ABLE TO BE MANIPULATED. UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED AND THE PROXIMAL END OF TIP DOME HAD FOREIGN MATERIAL OFF-WHITE TO REDDISH BROWN COLOR. IN ADDITION, RING 1 ON DISTAL SIDE HAD WHITE MATERIAL UNDERNEATH THE RING. DURING DECONTAMINATION THE FIRST FOREIGN MATERIAL MENTIONED WAS DISSOLVED. FOR THE WHITE MATERIAL A FT-IR TEST WAS PERFORMED IN ORDER TO IDENTIFY THE TYPE OF MATERIAL; THE RESULTS DEMONSTRATED THAT THE PARTICLE WAS MAINLY COMPOSED OF ACRYLATE ¿ BASED MATERIAL. IT IS UNKNOWN THE ORIGIN OF THE FOREIGN MATERIAL. 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. ALL THE CATHETERS ARE INSPECTED FOR VISUAL DAMAGES BEFORE PACKAGING. ON LINE INSPECTIONS ARE IN PLACE TO PREVENT FOREIGN MATERIAL FROM LEAVING THE FACILITY. THE REPORTED CUSTOMER COMPLAINT HAS BEEN VERIFIED. IN ADDITION, A CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS AND RESOLVE THE T BAR ISSUE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE STEERING MECHANISM OF THIS CATHETER FAILED AND THE CATHETER WAS NOT ABLE TO BE MANIPULATED. THE CASE WAS COMPLETED BY USING ANOTHER CATHETER WITHOUT ANY PATIENT CONSEQUENCE. UPON VISUAL INSPECTION OF THE RETURNED COMPLAINT CATHETER, ON JUNE 3, 2014 BWI FAILURE ANALYSIS LAB NOTED RING #1 ON DISTAL SIDE HAS WHITE MATERIAL UNDERNEATH THE RING MAKING THIS EVENT REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357339 THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-02-S UNK_D-1336-02-S

    Patients

    Seq Age Sex Outcome Treatment
    1