BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7F ES STEER DS BI-DIRECTIONAL NAV CATHETER

    MDR report key: 2914676 · Received January 14, 2013

    Report

    Report Number
    9673241-2013-00011
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P990025/S12
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED DURING AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) PROCEDURE, THE EZ STEER NAVIGATIONAL 4MM CATHETER DEVELOPED CHAR WHILE IN USE. UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. THE APPROXIMATE SIZE OF THE CHAR WAS 2 - 3 MM. THERE WAS NO PATIENT INJURY REPORTED IN THIS CASE. UPON RECEIPT, THE DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITIONS. NO CHAR WAS OBSERVED. THEN PER THE REPORTED EVENT, THE CATHETER WAS TESTED AND IT PASSED ELECTRICAL, TEMPERATURE AND GENERATOR TESTS. DURING THE INVESTIGATION, A FAILURE THAT WAS NON RELATED TO THE CHAR WAS FOUND. THE CATHETER FAILED THE CALIBRATION CHECK FOR THE NAVIGATION SYSTEM. THE CATHETER WAS DISSECTED AND IT WAS DETERMINED THAT THE ROOT CAUSE WAS A PC BOARD INTERNAL MALFUNCTION. 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 ABOUT CHAR CANNOT BE CONFIRMED, THE ROOT CAUSE OF THE CHAR REMAINS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) PROCEDURE, THE EZ STEER NAVIGATIONAL 4MM CATHETER DEVELOPED CHAR WHILE IN USE. THE POWER WAS SET TO 50 WATTS AND 60 DEGREES UNDER TEMPERATURE CONTROL. NO RISES OF TEMPERATURE OR IMPEDANCE WERE NOTICED. THE CATHETER WAS REPLACED AND THE CASE WAS CONTINUED. UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. THE APPROXIMATE SIZE OF THE CHAR WAS 2 - 3 MM. THERE WERE NO REDUCTION IN SIGNALS, SO THE PHYSICIAN CHECKED THE CATHETER. THE CHAR WAS NOTICED AFTER SEVERAL ABLATIONS. THE ABLATIONS WERE NO LONGER THAN 60 SECONDS EACH. THERE WAS NO PATIENT INJURY REPORTED IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21301 7F ES STEER DS BI-DIRECTIONAL NAV CATHETER ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1268-04-S 15672646M

    Patients

    Seq Age Sex Outcome Treatment
    1