BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 3954717 · Received July 24, 2014

    Report

    Report Number
    9673241-2014-00279
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    December 17, 2013
    Report Date
    January 13, 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).

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT THE SMART TOUCH CATHETER HAD ERROR 106. DATA STREAMING ERROR WAS ALSO DISPLAYED UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED AND IT WAS FOUND THAT RING 1 WAS DAMAGED AND HAD SOME WHITE PARTICLE UNDERNEATH. THIS CONDITION WAS NOT ORIGINALLY REPORTED ON THE COMPLAINT. A FT-IR TEST WAS PERFORMED IN ORDER TO IDENTIFY THE TYPE OF FOREIGN MATERIAL; THE RESULTS DEMONSTRATED THAT THE PARTICLE IS PRIMARILY COMPOSED OF A POLYETHER AMIDE ¿ BASED MATERIAL. IT IS UNKNOWN HOW THE RING WAS DAMAGED AND THE ORIGIN OF THE FOREIGN MATERIAL. DUE TO THIS CONDITION, THE CATHETER OUTER DIAMETERS WERE MEASURED AND IT WAS FOUND WITHIN SPECIFICATIONS. THEN PER THE REPORTED EVENT, THE CATHETER WAS TESTED ON CARTO 3 AND CATHETER FAILED. THE CATHETER WAS THEN DISSECTED AND IT WAS DETERMINED THAT THE ROOT CAUSE WAS AN INTERNAL FAILURE OF THE FORCE SENSOR. 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 DAMAGE RINGS FROM LEAVING THE FACILITY. THE REPORTED CUSTOMER COMPLAINT HAS BEEN VERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE TRANSSEPTAL PUNCTURE HAD BEEN PERFORMED AND THE MAP WAS ABOUT TO BE CREATED. THERE WAS ERROR 106 (DATA STREAMING ERROR) WAS DISPLAYED ON THE CARTO. THE CATHETER INTERFACE CABLE WAS REPLACED AND THE SYSTEM REBOOTED HOWEVER THERE WAS NO RESOLUTION. THE ISSUE WAS RESOLVED BY REPLACING THE ST CATHETER. THE CASE WAS COMPLETED WITHOUT ANY PATIENT CONSEQUENCE. NO ABLATION WAS PERFORMED. UPON RECEIVING THE PRODUCT IN BIOSENSE WEBSTER LAB ON JULY 5TH 2014, IT WAS NOTICED THAT SMALL WHITE MATERIAL UNDERNEATH RING #1 PROXIMAL SIDE, MAKING THIS EVENT REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432990 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-05-S UNK_D-1327-05-S

    Patients

    Seq Age Sex Outcome Treatment
    1