BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AZURION

    MDR report key: 19839536 · Received July 26, 2024

    Report

    Report Number
    3003768277-2024-04046
    Event Type
    Injury
    Date Received
    July 26, 2024
    Date of Event
    July 18, 2024
    Report Date
    June 3, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838085251
    PMA / PMN Number
    K163715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS FURTHER INVESTIGATED THIS COMPLAINT. ACCORDING TO ADDITIONAL INFORMATION RECEIVED, ON (B)(6) 2024 WHILE CHECKING STENT PLACEMENT AFTER DEPLOYMENT, THE FLUOROSCOPY BECAME UNAVAILABLE. A SYSTEM RESTART DID NOT RESTORE THE FLUOROSCOPY FUNCTION. CONSEQUENTLY, THE PHYSICIAN WAS UNABLE TO VERIFY OR ADJUST THE STENT PLACEMENT BEFORE ENDING THE PROCEDURE. TWO DAYS LATER, ON (B)(6) 2024, THE PATIENT'S STENT DEVELOPED THROMBOSIS, ALLEGEDLY DUE TO THE INACCURATE STENT POSITION. PHILIPS BECAME AWARE OF THE STENT THROMBOSIS ON (B)(6) 2024. THE PATIENT UNDERWENT A SECOND PROCEDURE WITH A POSITIVE OUTCOME. AN ON-SITE INSPECTION AND REVIEW OF SYSTEM LOG FILES CONFIRMED A "POINT: RESONANCE FREQUENCY TOO LOW" ERROR. THE USER WAS PROVIDED A USER GUIDANCE/WARNING MESSAGE INDICATING ¿GRID LEAKAGE CURRENT OUT OF RANGE.¿ TO RESOLVE THE ISSUE, A PHILIPS FIELD SERVICE ENGINEER (FSE) REPLACED THE X-RAY TUBE. THE X-RAY TUBE WAS RETURNED FOR FURTHER ANALYSIS. THE ROOT CAUSE OF THE ISSUE WAS CONFIRMED TO BE A DISTORTED SMALL FILAMENT. THE DISTORTED SMALL FILAMENT CAUSED THE SYSTEM TO AUTOMATICALLY DISABLE THE GRID SWITCH FUNCTION WHICH IN TURN CAUSED THE USER GUIDANCE MESSAGE INDICATING "GRID LEAKAGE CURRENT OUT OF RANGE". AFTER REPLACEMENT OF THE X-RAY TUBE AND FUNCTIONAL CHECKS, THE SYSTEM WAS CONFIRMED TO BE OPERATING WITHIN SPECIFICATIONS AND RETURNED TO CLINICAL USE. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A REPORT THAT, NEAR THE END OF A CORONAROGRAPHY PROCEDURE WITH STENT DILATATION, X-RAY AND FLUOROSCOPY BECAME UNAVAILABLE. THE PHYSICIAN DEPLOYED THE STENT AND ENDED THE PROCEDURE. IT WAS LATER REPORTED TO PHILIPS THAT TWO DAYS AFTER THE PROCEDURE, THE PATIENT DEVELOPED STENT THROMBOSIS DUE TO INACCURATE POSITIONING. A SECOND PROCEDURE WAS COMPLETED ON (B)(6) 2024 WITH A POSITIVE OUTCOME. AN INVESTIGATION INTO THIS COMPLAINT HAS BEEN INITIATED BY PHILIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485195 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M12 00884838085251

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O