BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER

    MDR report key: 6054844 · Received October 25, 2016

    Report

    Report Number
    9673241-2016-00729
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    September 13, 2016
    Report Date
    September 13, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    MTD
    PMA / PMN Number
    K123837
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REF. NO: (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) PROCEDURE WITH A PENTARAY NAVIGATIONAL ECO CATHETER. INITIALLY THERE WAS NOISE ON ELECTRODE # 2 BEING DISPLAYED ON THE RECORDING SYSTEM. IT WAS ALSO REPORTED THAT THE ELECTRODE WAS BLACKED OUT ON THE CARTO 3 SYSTEM. THE CABLE WAS REPLACED WITH NO RESOLUTION. WHEN THE CATHETER WAS REPLACED, THE ISSUE RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. THE DEVICE WAS VISUALLY INSPECTED AND CATHETER SPINES WERE FOUND DAMAGED WITH ELECTRODES LIFTED AND SHARP. PER THESE CONDITIONS THE CATHETER OUTER DIAMETERS WERE MEASURED AND IT WAS FOUND WITHIN SPECIFICATIONS. FURTHER INFORMATION RECEIVED INDICATES THAT 8.5 FR SHEATH WAS USED DURING THE PROCEDURE WHILE THE INSTRUCTIONS FOR USE (IFU) INDICATES THAT AN 8 FRENCH IS RECOMMENDED AS THE DISTAL SPINES MAY BE DAMAGED IF USED WITH A SHEATH THAT IS NOT COMPATIBLE. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED SINCE THE CATHETER DAMAGE WAS NOT NOTICED OR MENTIONED BY THE DOCTOR. DURING MANUFACTURING PROCESS ALL CATHETERS ARE INSPECTED FOR VISUAL DAMAGES BEFORE THE PACKAGING. THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE AND IT WAS FOUND WITHIN SPECIFICATIONS. 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 REGARDING A BLACK OUT ELECTRODE AND NOISE HAS NOT BEEN CONFIRMED. BASED ON THE AVAILABLE ANALYSIS FINDING RESULTS, THE SPINES FAILURE MODE OBSERVED DOES NOT APPEAR TO BE CAUSED BY ANY INTERNAL BIONSENSE WEBSTER, INC. PROCESSES, SINCE SEVERAL INSPECTIONS ARE IN PLACE TO AVOID THESE KINDS OF FAILURES. ALSO AN 8F GUIDING SHEATH IS RECOMMENDED AS THE DISTAL SPINES MAY BE DAMAGED IF USED WITH A SHEATH THAT IS NOT COMPATIBLE.

    Additional Manufacturer Narrative · 1

    THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: C3 ECO INTERFACE CABLE, MODEL #: D-1344-01-S, LOT #: 17439925L. (B)(4). EVENT DESCRIPTION CONTINUATION: THE BENT SPLINES WITH NO EXPOSED WIRES WERE ASSESSED AS NOT REPORTABLE AS THE POTENTIAL THAT THEY COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, WAS REMOTE. THE SHARP RINGS WERE ASSESSED AS REPORTABLE MALFUNCTIONS AS THE SHARP ELECTRODE RINGS MAY CAUSE DAMAGE TO VASCULAR ENDOTHELIAL LININGS DURING THE WITHDRAWAL OF THE CATHETER AND SHEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) PROCEDURE WITH A PENTARAY NAVIGATIONAL ECO CATHETER. INITIALLY THERE WAS NOISE ON ELECTRODE # 2 BEING DISPLAYED ON THE RECORDING SYSTEM. IT WAS ALSO REPORTED THAT THE ELECTRODE WAS BLACKED OUT ON THE CARTO 3 SYSTEM. THE CABLE WAS REPLACED WITH NO RESOLUTION. WHEN THE CATHETER WAS REPLACED, THE ISSUE RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. THIS EVENT WAS ASSESSED AS NOT REPORTABLE AS THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS DETERIORATION IN STATE OF HEALTH WAS REMOTE. THE BIOSENSE WEBSTER FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND DISCOVERED ON (B)(6) 2016 THAT THE SPLINE A WAS BENT BETWEEN THE MARKER AND ELECTRODE RING #2, WITH MARKER ELECTRODE RING SHARP ON THE PROXIMAL SIDE. THE SPLINE WAS BENT AGAIN AT THE PROXIMAL SIDE ELECTRODE RING #2. SPLINE B AT ELECTRODE RING #6 HAD A SMALL AREA SHARP ON THE PROXIMAL SIDE. THE SPLINE WAS BENT ABOUT 2MM FROM ELECTRODE RING #7. SPLINE C ON ELECTRODE RING #10 HAD A SMALL AREA SHARP ON THE PROXIMAL SIDE. SPLINE D WAS SLIGHTLY BENT 1MM FROM ELECTRODE RING #15. SPLINE E WAS SLIGHTLY BENT BETWEEN ELECTRODE RING #18 AND ELECTRODE RING #19. ADDITIONAL CLARIFICATION WAS REQUESTED AND RECEIVED ON THE RETURNED CATHETER CONDITION. THEY DID NOT RECALL ANY RESISTANCE WHILE INTRODUCING OR RETRACTING THE CATHETER FROM THE SHEATH. THIS CATHETER CONDITION WAS NOT OBSERVED BY THE BIOSENSE WEBSTER REPRESENTATIVE AND IT WAS ALSO NOT MENTIONED BY THE PHYSICIAN. THE ST. JUDE SL2 8.5FR SHEATH WAS USED. NO PATIENT CONSEQUENCES WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706464 PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER, INC. (JUAREZ) D-1282-08-S 17534568L

    Patients

    Seq Age Sex Outcome Treatment
    1