BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 3070845 · Received April 22, 2013

    Report

    Report Number
    9673241-2013-00118
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    P990025
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER MULTIPLE ATTEMPTS TO RETRIEVE THE DEVICE, THE PRODUCT WAS NOT RETURNED FOR BWI INVESTIGATION AS INITIALLY REPORTED. DEVICE HISTORY RECORDS 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. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: STOCKERT 70 SYSTEM US: CATALOG #: S7001, SERIAL #: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AVRT (ATRIOVENTRICULAR REENTRANT TACHYCARDIA) / WPW (WOLFF-PARKINSON-WHITE SYNDROME) PROCEDURE, THE STOCKERT WAS IMMEDIATELY REACHING THE PROGRAMMED TEMPERATURE AND DELIVERING VERY LOW WATTS DURING THIS ACCESSORY PATHWAY ABLATION. A NAVISTAR CATHETER WAS IN USE IN THE SEPTAL ANNULUS AND IT WAS NOT PULLED BACK INTO THE SHEATH. THE STOCKERT TEMPERATURE CONTROL SETTINGS WERE 60 DEGREES AND 50 WATTS. ACCORDING TO THE REPORTER, THE START BUTTON WAS PRESSED AND THE TEMPERATURE WOULD IMMEDIATELY READ 60 DEGREES WITH 0 TO 1 WATT DELIVERED. THE REDEL CABLE, REDEL ADAPTOR, AND NAVISTAR CABLE WERE CHANGED WITH THE SAME ISSUE. TROUBLESHOOTING WAS PERFORMED BY CHANGING THE NAVISTAR CATHETER AND BY REBOOTING THE STOCKERT BUT IT DID NOT RESOLVE THE ISSUE. AFTER FOLLOW UP WITH THE CUSTOMER TO OBTAIN DETAILED INFORMATION REGARDING THE EVENT IT WAS STATED THAT RF WAS BEING DELIVERED, ROUGHLY 10 WATTS. THE TEMPERATURE WAS NOT "TOO HIGH" BUT THE DESIRED TEMPERATURE WAS ACHIEVED QUICKLY AT 10 WATTS WHILE THE CUSTOMER WAS USING THE STOCKERT IN TEMPERATURE MODE. THERE WAS NO ERROR MESSAGE SHOWED. THE CLINICAL SPECIALIST EXPLAINED TO THE LAB STAFF THAT THE STOCKERT WAS OPERATING AS IT SHOULD IN TEMPERATURE MODE. THE PHYSICIAN WAS JUST UNCOMFORTABLE WITH HOW THE SYSTEM WAS "ACTING" AND REQUESTED THE STOCKERT TO BE EVALUATED AND THE CATHETER REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173133 NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1183-08-S 15470148M

    Patients

    Seq Age Sex Outcome Treatment
    1