BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVI-STAR¿ RMT ELECTROPHYSIOLOGY CATHETER

    MDR report key: 3200653 · Received July 1, 2013

    Report

    Report Number
    9673241-2013-00218
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 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
    TX, 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 IDIOPATHIC VENTRICULAR TACHYCARDIA - RIGHT (R-IDVT) PROCEDURE, THAT THERE WAS CHAR BUILD-UP ON THE NAVISTAR RMT 4MM CATHETER WHILE ABLATING IN THE POSTERIOR RIGHT VENTRICULAR OUTFLOW TRACT - (RVOT). PARAMETERS ON STOCKERT WERE 65 DEGREES, 50 WATTS. THE IMPEDANCE WOULD RISE AND THEN THE STOCKERT WOULD STOP ABLATING AND WOULD GIVE THE DELTA IMPEDANCE ERROR. NO TROUBLESHOOTING HAD BEEN DONE AND NONE WAS REQUESTED. THERE HAD BEEN NO NEGATIVE PATIENT IMPACT. UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. ABLATION WAS ATTEMPTED TWICE AT THIS SITE. NOT LASTING MORE THAN 10-15 SECONDS DUE TO THE IMPEDANCE CHANGE. THE GENERATOR WAS IN POWER CONTROL MODE. THE EXACT SIZE OF THE CHAR WAS UNKNOWN BECAUSE THE PHYSICIAN REMOVED THE CHAR FROM THE CATHETER MORE THAN ONCE IN ORDER TO CONTINUE ABLATING. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND THE TIP AREA HAD CHAR. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY AND IT WAS FOUND WITHIN SPECIFICATIONS. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS FAILURE MODE. DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE CUSTOMER COMPLAINT HAS BEEN VERIFIED. HOWEVER, THE CATHETER MET MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN IDIOPATHIC VENTRICULAR TACHYCARDIA - RIGHT (R-IDVT) PROCEDURE, THAT THERE WAS CHAR BUILD-UP ON THE NAVISTAR RMT 4MM CATHETER WHILE ABLATING IN THE POSTERIOR RIGHT VENTRICULAR OUTFLOW TRACT - (RVOT). PARAMETERS ON STOCKERT WERE 65 DEGREES, 50 WATTS. THE IMPEDANCE WOULD RISE AND THEN THE STOCKERT WOULD STOP ABLATING AND WOULD GIVE THE DELTA IMPEDANCE ERROR. NO TROUBLESHOOTING HAD BEEN DONE AND NONE WAS REQUESTED. THERE HAD BEEN NO NEGATIVE PATIENT IMPACT. UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. ABLATION WAS ATTEMPTED TWICE AT THIS SITE. NOT LASTING MORE THAN 10-15 SECONDS DUE TO THE IMPEDANCE CHANGE. THE GENERATOR WAS IN POWER CONTROL MODE. THE EXACT SIZE OF THE CHAR WAS UNKNOWN BECAUSE THE PHYSICIAN REMOVED THE CHAR FROM THE CATHETER MORE THAN ONCE IN ORDER TO CONTINUE ABLATING. DUE TO THE UNKNOWN EXACT SIZE OF THE CHAR, BECAUSE THE PHYSICIAN REMOVED THE CHAR FROM THE CATHETER MORE THAN ONCE IN ORDER TO CONTINUE ABLATING, IS INDICATIVE OF A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297990 NAVI-STAR¿ RMT ELECTROPHYSIOLOGY CATHETER ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1257-02-S 15659793M

    Patients

    Seq Age Sex Outcome Treatment
    1