BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER

    MDR report key: 5618500 · Received April 28, 2016

    Report

    Report Number
    9673241-2016-00303
    Event Type
    Injury
    Date Received
    April 28, 2016
    Date of Event
    April 8, 2016
    Report Date
    April 11, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    MTD
    PMA / PMN Number
    K123837
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 17428250L HAS BEEN REVIEWED AND IT WAS VERIFIED THAT DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES.

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. (B)(4). THE DEVICE WAS NOT RETURNED TO BWI.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A PENTARAY NAV ECO 7 FRENCH CATHETER AND SUFFERED A MEDICAL DEVICE ENTRAPMENT REQUIRING SURGICAL INTERVENTION. THE PENTARAY SPINE WITH ELECTRODES 17-18 AND 19-20 GOT ENTRAPPED IN THE MECHANICAL MITRAL VALVE. THE SEPTAL FIN BECAME STUCK IN THE CLOSED POSITION. THE SPINE OF THE CATHETER WAS REMOVED FROM THE MECHANICAL MITRAL VALVE VIA FEMORAL VEIN ACCESS USING A DEFLECTABLE SHEATH AND A LASSO-TYPE CATHETER. THE FEMORAL VEIN ACCESS WHICH WAS ESTABLISHED DURING THE CARTO CASE FOR ATRIAL FIBRILLATION ABLATION WAS REMOVED AT THE END OF THE CASE. A NEW ACCESS WAS USED 3 DAYS LATER TO RETRIEVE THE PENTARAY SPINE. UPON REMOVAL OF THE PENTARAY SPINE, MECHANICAL VALVE FUNCTION WAS RESTORED. PATIENT WAS FULLY RECOVERED WITH NO RESIDUAL EFFECTS. ON APRIL 14, 2016, BIOSENSE WEBSTER INC. INITIATED A VOLUNTARY LABELING CORRECTION TO CLARIFY AN EXISTING CONTRAINDICATION RELATIVE TO PATIENTS WITH PROSTHETIC VALVES IN THE INSTRUCTIONS FOR USE (IFU) FOR ALL PENTARAY CATHETERS. THE CURRENT LANGUAGE IN THE IFU PROVIDES A PRECAUTION AGAINST USE OF THE PENTARAY CATHETER IN PATIENTS WITH PROSTHETIC VALVES UNDER THE CONTRAINDICATION SECTION STATING: "[THE] USE OF THIS CATHETER MAY NOT BE APPROPRIATE FOR USE IN PATIENTS WITH PROSTHETIC VALVES." WE ARE UPDATING THE IFU TO CLARIFY THE CONTRAINDICATION STATEMENT AS FOLLOWS: "DO NOT USE PENTARAY CATHETERS IN PATIENTS WITH PROSTHETIC VALVES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273016 PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER, INC. (JUAREZ) D-1282-08-S 17428250L

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other| R