BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 4155675 · Received October 9, 2014

    Report

    Report Number
    9673241-2014-00413
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 10, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIMILAR DEVICE D133601, PMA # P030031/S053. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT THE CATHETER WAS BROKEN AT THE POSITION OF AROUND 10 CM TO THE TIP OF IT UPON RECEIPT, THE DEVICE WAS VISUALLY INSPECTED AND SHAFT WAS BROKEN ABOUT 3 CM PROXIMAL FROM ELECTRODE 6 LEAVING INTERNAL WIRES EXPOSED. THE EVIDENCE SUGGESTED THAT AN EXTERNAL FORCE (E.G. TORQUE OR TWISTING) WAS APPLIED OVER THE DAMAGE AREA. ALL THE CATHETERS ARE INSPECTED FOR VISUAL DAMAGES BEFORE PACKAGING. ON LINE INSPECTIONS ARE IN PLACE TO PREVENT THIS TYPE OF DAMAGE/DEFECT FROM LEAVING THE FACILITY. IT REMAINS UNKNOWN HOW THE SHAFT WAS DAMAGED. DUE TO THE EXPOSED WIRES, AN ELECTRICAL TEST WAS PERFORMED AND CATHETER PASSED. THEREFORE, WE CAN CONCLUDE ALL THE ELECTRICAL WIRES WERE INSULATED 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 IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED AND AVOID TWISTING THE CATHETER TO PREVENT ANY DAMAGE. THE REPORTED CUSTOMER COMPLAINT HAS BEEN VERIFIED. IN ADDITION, A CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS AND RESOLVE THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER WAS BROKEN AT THE POSITION AROUND 10 CM TO THE TIP. THE CASE WAS COMPLETED BY CHANGING THE CATHETER WITHOUT ANY PATIENT CONSEQUENCE. ON (B)(6) 2014, BWI RECEIVED INFORMATION WHICH THE CUSTOMER STATED THE DAMAGE DID NOT RESULT ANY WIRE EXPOSED IN THE CATHETER. THERE WAS NO DIFFICULTY TO REMOVE THE CATHETER. UPON VISUAL INSPECTION OF THE RETURNED COMPLAINT CATHETER, ON OCTOBER 2 2014, BWI FAILURE ANALYSIS LAB NOTED SHAFT IS BROKEN ABOUT 3CM PROXIMAL FROM ELECTRODE #6 LEAVING INTERNAL WIRES EXPOSED, MAKING THIS EVENT REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634917 THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-04IL-S 16082692M

    Patients

    Seq Age Sex Outcome Treatment
    1