BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVI-STAR¿ RMT ELECTROPHYSIOLOGY CATHETER

    MDR report key: 3240454 · Received July 22, 2013

    Report

    Report Number
    9673241-2013-00243
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 27, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P990025/S9
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF # (B)(4). IT WAS REPORTED THAT DURING AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT), THIS CATHETER HAD A HIGH IMPEDANCE VALUE OF 170 OHMS AT THE RIGHT ATRIUM AND 250 OHMS AT THE CORONARY SINUS. THE CABLE WAS EXCHANGED AND LOCATION OF THE GROUNDING PATCH MOVED WITH NO RESOLUTION. IMPEDANCE CUT OFF WAS 250 OHMS BUT NEVER REACHED THE CUTOFF POINT. THERE WERE NO ERRORS OR WARNING MESSAGES. THE CATHETER WAS EXCHANGED WITH NO REDUCTION OF IMPEDANCE BUT WHEN THEY START RF WITH THE SECOND CATHETER, THERE WAS A REDUCTION OF IMPEDANCE AND THE CASE WAS COMPLETED WITH THE USE OF THE SECOND CATHETER. UPON RECEIPT, THE DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND THAT THE TIP HAD CHAR. THEN PER THE REPORTED EVENT, THE CATHETER WAS TESTED AND IT PASSED ELECTRICAL, TEMPERATURE AND GENERATOR TESTS. THE DEVICE HISTORY RECORD 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 CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE CHAR REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT ON DEVICE EVALUATION WILL BE SUBMITTED ONCE IT IS COMPLETED. THE CONCOMITANT PRODUCT: STOCKERT MODEL# M-5463-01, SERIAL (B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT), THIS CATHETER HAD A HIGH IMPEDANCE VALUE OF 170 OHMS AT THE RIGHT ATRIUM AND 250 OHMS AT THE CORONARY SINUS. THE CABLE WAS EXCHANGED AND LOCATION OF THE GROUNDING PATCH MOVED WITH NO RESOLUTION. IMPEDANCE CUT OFF WAS 250 OHMS BUT NEVER REACHED THE CUT OFF POINT. THERE WERE NO ERRORS OR WARNING MESSAGES. THE CATHETER WAS EXCHANGED WITH NO REDUCTION OF IMPEDANCE BUT WHEN THEY START RF WITH THE SECOND CATHETER, THERE WAS A REDUCTION OF IMPEDANCE AND THE CASE WAS COMPLETED WITH THE USE OF THE SECOND CATHETER. ON (B)(4) 2013, UPON RECEIVING THE PRODUCT IN BIOSENSE WEBSTER LAB, IT WAS NOTICED THAT CHAR FOUND ON THE TIP OF CATHETER MAKING THIS EVENT REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340119 NAVI-STAR¿ RMT ELECTROPHYSIOLOGY CATHETER ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1257-02-S 15800586M

    Patients

    Seq Age Sex Outcome Treatment
    1