BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTARAY NAV

    MDR report key: 20723763 · Received November 19, 2024

    Report

    Report Number
    2029046-2024-03720
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Date of Event
    October 24, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835012224
    PMA / PMN Number
    K123837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J) FOR EVALUATION. VISUAL INSPECTION AND IRRIGATION TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING J&J PROCEDURES. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. IRRIGATION TESTING WAS PERFORMED AND NO ISSUES WERE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE IRRIGATION ISSUE REPORTED BY THE CUSTOMER COULD NOT BE REPLICATED DURING THE PRODUCT INVESTIGATION; OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USAGE OF THE DEVICE THAT COMPROMISED ITS PERFORMANCE. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING WARNING AND PRECAUTIONS: PURGE THE CATHETER AND THE IRRIGATION TUBING WITH HEPARINIZED NORMAL SALINE PRIOR TO INSERTION OF THE CATHETER INTO THE PATIENT. INSPECT THE IRRIGATION SALINE FOR AIR BUBBLES PRIOR TO ITS USE IN THE PROCEDURE. AIR BUBBLES IN THE IRRIGATION SALINE MAY CAUSE EMBOLI. ALWAYS MAINTAIN A CONSTANT HEPARINIZED NORMAL SALINE INFUSION TO PREVENT COAGULATION WITHIN THE LUMEN OF THE CATHETER. DO NOT USE THE CATHETER WITHOUT IRRIGATION FLOW. AS PART OF JOHNSON & JOHNSON MEDTECH'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PERSISTENT ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV AND AN IRRIGATION ISSUE OCCURRED. IT WAS REPORTED FLUSHING ON THE PENTARAY NAV STOPPED DURING THE PROCEDURE FOR NO APPARENT REASON. THEY TRIED MANUALLY RINSING THE CATHETER WITH A SYRINGE, BUT HERE TOO NO RINSING WAS POSSIBLE. THE IRRIGATION LINE RAN NORMALLY WITHOUT THE CATHETER CONNECTED. RINSE WITH 500 ML NACL AND 1000 IU HEPARIN USING A PRESSURE BAG. THE CATHETER WAS THEN EXCHANGED FOR A NEW ONE AND CONTINUED TO FUNCTION WITHOUT ANY PROBLEMS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92647 PENTARAY NAV CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31427994L 10846835012224

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN PRESSURE BAG| UNKNOWN SYRINGE