BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSURE WIRE AERIS G8

    MDR report key: 7379324 · Received March 28, 2018

    Report

    Report Number
    3008452825-2018-00097
    Event Type
    Injury
    Date Received
    March 28, 2018
    Date of Event
    March 8, 2018
    Report Date
    March 28, 2018
    Manufacturer
    ST. JUDE MEDICAL, COSTA RICA LTDA
    Product Code
    DXO
    PMA / PMN Number
    K131452
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF PRESSURE REGISTRATION ISSUE COULD NOT BE CONFIRMED. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED PRESSUREWIRE. THE PRESENCE OF A DRIED SALT-LIKE SUBSTANCE INSIDE THE COVERING OF THE SENSOR ELEMENT CAN AFFECT SIGNAL READINGS, WHICH PRECLUDES FURTHER SIGNAL TESTING. ELECTRICAL TESTING OF THE GUIDEWIRE REVEALED NO ANOMALIES. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE CAUSE OF THE REPORTED PRESSURE REGISTRATION ISSUE REMAINS UNKNOWN. THE PRESSUREWIRE INSTRUCTIONS FOR USE (IFU) STATES THAT FALSE READING MAY OCCUR IF THE MALE CONNECT IS: NOT DRY, CLEAN AND FREE OF COAGULATED BLOOD, NOT FULLY INSERTED INTO THE BOTTOM OF THE TRANSMITTER (INDICATED BY YELLOW LIGHT), BENT OR DAMAGED. THE PRESSUREWIRE INSTRUCTIONS FOR USE (IFU) STATES FOR OPTIMAL PRESSURE MEASUREMENT ADJUST THE POSITION OF PRESSUREWIRE SO THAT THE SENSOR DOES NOT TOUCH THE ATRIAL OR VENTRICULAR WALLS, TO AVOID MEASUREMENT DUE TO MOVEMENT.

    Description of Event or Problem · 1

    A PRESSUREWIRE AERIS WAS ATTEMPTED TO BE USED BUF FAILED TO EQUALIZE DUE TO DRIFT. THE BASAL CURVE WAS 120/80 AND THE OTHER WAS 170/118. MULTIPLE ATTEMPTS WERE MADE TO RESOLVE THE ISSUE BUT THE DRIFT CONTINUED. AFTER AN HOUR OF FAILED ATTEMPTS, A NEW PRESSUREWIRE AERIS WAS USED AND WORKED CORRECTLY AND INSTANTLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCE, HOWEVER, THE PROCEDURE WAS EXTENDED FOR 1 HOUR DUE TO EQUALIZATION ISSUES WITH THE DEVICE. THE PHYSICIAN CONSIDERED THE DELAY CLINICALLY SIGNIFICANT FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221446 PRESSURE WIRE AERIS G8 TRANSDUCER, PRESSURE,CATHETER TIP DXO ST. JUDE MEDICAL, COSTA RICA LTDA C12058 5539020

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention