BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLURA XPER FD20/10 & ALLURA XPER FD20/20

    MDR report key: 14249782 · Received April 29, 2022

    Report

    Report Number
    3003768277-2022-00186
    Event Type
    Injury
    Date Received
    April 29, 2022
    Date of Event
    April 15, 2022
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    PMA / PMN Number
    K033737
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS INSPECTED THE SYSTEM ONSITE AND REVIEWED LOG AND TRACE FILES. BASED ON PRELIMINARY RESULTS, NO MALFUNCTION OF THE SYSTEM HAS BEEN IDENTIFIED. PHILIPS IS FURTHER INVESTIGATING TO IDENTIFY THE CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. THE CUSTOMER ALLEGED TWO SIMILAR INCIDENTS WHERE NOISE WAS VISIBLE ON THE SCREEN JUST PRIOR TO GLUE INJECTION. ONE PROCEDURE WAS USING ONYX LIQUID EMBOLIC AND ONE USING SQUID LIQUID EMBOLIC. THIS COMPLAINT IS REGARDING THE PROCEDURE IN WHICH SQUID LIQUID EMBOLIC WAS USED. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, WHEN THE CUSTOMER INJECTED THE SQUID LIQUID EMBOLIC AND INITIATED X-RAY VIA THE FOOT PEDAL, THE INJECTION COULD NOT BE CONTROLLED AS THE IMAGE WAS STILL AND DID NOT SHOW THE PROGRESS OF THE EMBOLIC. THE IMAGE SUDDENLY ¿REFRESHED¿ AND IT WAS SEEN THAT HEALTHY TISSUE WAS EMBOLIZED. THE ISSUE OCCURRED DURING AN ARTERIOVENOUS MALFORMATION PROCEDURE. AS PER THE USER, THE FINAL STATUS OF THE PATIENT WAS OKAY, NO FURTHER DETAILS WERE PROVIDED ABOUT THE PATIENT. PHILIPS HAS ANALYZED THE LOG FILE AND IMAGES AND INSPECTED THE SYSTEM ONSITE. ANALYSIS OF THE IMAGES CONFIRMED THE EMBOLIZATION OF HEALTHY TISSUE. NO FAILURE WAS FOUND IN THE LOG FILE OR VIA VISUAL INSPECTION OF THE SYSTEM. BASED ON THE ANALYSIS OF THE AVAILABLE INFORMATION PHILIPS HAS NOT BEEN ABLE TO DETERMINE THE ACTUAL ROOT CAUSE. TWO POTENTIAL CAUSES WERE IDENTIFIED: IN THE LOG FILE, A DELAY IN RESPONSE TIME OF THE FOOTSWITCH WAS SEEN WITH TWO SPIKES UP TO 1.8 SECONDS (NORMALLY ~0.8 SECONDS) WHICH MAY HAVE CAUSED A SHORT DELAY IN BETWEEN PRESSING AND STARTING THE LIVE IMAGE. IT CANNOT BE CONFIRMED IF THIS DELAY CAUSED THE ¿FREEZE¿ DESCRIBED BY THE CUSTOMER. IF THE MICROCATHETER IS NOT WELL FLUSHED, THE ROADMAPPING WILL NOT SHOW THE ADVANCE OF EMBOLIC OVER THE CATHETER AND THE FIRST EMBOLIC MAY SUDDENLY APPEAR. PHILIPS HAS COMPLETED A GOOD FAITH EFFORT TO GET FURTHER INFORMATION ON HOW THE PROCEDURE WAS PERFORMED, HOWEVER, THE CUSTOMER REFUSED TO PROVIDE FURTHER INFORMATION TO FURTHER INVESTIGATE THE REPORTED PROBLEM. AT THE REQUEST OF THE CUSTOMER, THE SYSTEM HAS BEEN UNINSTALLED ON (B)(6) 2023.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT DURING A CEREBRAL AVM WITH THE PHILIPS ALLURA SYSTEM USING ONYX/SQUID LIQUID EMBOLIC, THERE WAS ¿POOR¿ VISUALIZATION. THE PHYSICIAN REPORTED THAT WHILE HE WAS INJECTING THE LIQUID EMBOLIZING TREATMENT INITIALLY, NOTHING WAS VISUALIZED. THEN THERE WAS A LOT OF THE PRODUCT THAT APPEARED ON THE SCREEN. THIS REPORTEDLY RESULTED IN EMBOLIZATION OF NON-INTENDED, HEALTHY TISSUE. PHILIPS HAS INITIATED AN INVESTIGATION INTO ANY POSSIBLE INVOLVEMENT OF THE PHILIPS ALLURA SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100555 ALLURA XPER FD20/10 & ALLURA XPER FD20/20 INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20/10 & FD20/20

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening