BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSUREWIRE X, WIRELESS, RX 175CM

    MDR report key: 10372446 · Received August 6, 2020

    Report

    Report Number
    3008452825-2020-00369
    Event Type
    Injury
    Date Received
    August 6, 2020
    Date of Event
    March 12, 2020
    Report Date
    August 18, 2020
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DQX
    UDI-DI
    05415067025715
    PMA / PMN Number
    K161171
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, D1, D2, D3, D4, D10, G4, H2, H3, H4, H6 IT WAS INITIALLY REPORTED THAT AN EXPIRED CATHETER WAS OPENED AND USED FOR THE PROCEDURE, WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. UPDATED INFORMATION RECEIVED ON 12AUG20 WAS THAT THE INCORRECT CATHETER WAS INITIALLY REPORTED. BASED ON THE NEW CATHETER INFORMATION RECEIVED, THE DEVICE WAS NOT EXPIRED AT THE TIME OF USE AND NO LONGER MEETINGS REPORTING CRITERIA.

    Description of Event or Problem · 0

    DURING THE PROCEDURE, THE SIGNAL DRIFTED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES.

    Additional Manufacturer Narrative · 1

    ONE PRESSURE WIRE X, WIRELESS WAS RETURNED FOR ANALYSIS. INITIAL TESTING CONFIRMED THE PRESENCE OF A DRIED BLOOD-LIKE SUBSTANCE INSIDE THE COVERING OF THE SENSOR ELEMENT, WHICH CAN AFFECT SIGNAL READINGS, WHICH PRECLUDES FURTHER SIGNAL TESTING. THE RESULTS OF THE INVESTIGATION ALSO CONFIRMED THAT PRESSUREWIRE X, WIRELESS, BATCH NUMBER 6242420, EXPIRED ON 30 NOV 2019 WHICH WAS PRIOR TO THE REPORTED EVENT DATE OF (B)(6) 2020. A REVIEW OF DISTRIBUTION RECORDS CONFIRMED THAT THIS PRODUCT WAS DISTRIBUTED PRIOR TO ITS EXPIRATION DATE. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED, INCLUDING VERIFICATION OF THE EXPIRATION DATE LISTED ON THE PRODUCT LABEL. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE CAUSE OF THE USE OF EXPIRED PRODUCT IS CONSISTENT WITH USER ERROR.

    Description of Event or Problem · 1

    AN EXPIRED CATHETER WAS OPENED AND USED FOR A PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838785 PRESSUREWIRE X, WIRELESS, RX 175CM WIRE, GUIDE, CATHETER DQX ST. JUDE MEDICAL C12059 6242420 05415067025715

    Patients

    Seq Age Sex Outcome Treatment
    1 Other