BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLURA XPER FD20

    MDR report key: 4619442 · Received March 18, 2015

    Report

    Report Number
    3003768277-2015-00017
    Event Type
    Injury
    Date Received
    March 18, 2015
    Date of Event
    February 16, 2015
    Report Date
    February 23, 2015
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    OWB
    PMA / PMN Number
    K141979
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE SENT TO FDA.

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE CAUSE OF THIS EVENT SHOWED THAT THERE WAS NO SYSTEM MALFUNCTION. THE LOG FILES SHOWED THE DOCTOR REMAINED ON LOW FLUOROSCOPY DURING THE ENTIRE PROCEDURE. THE PHYSICIAN WAS AWARE OF THE POSSIBILITY TO INCREASE DOSE LEVEL, FOR BETTER VISIBILITY, BUT DID NOT USE THIS FUNCTIONALITY. THE INJURY WAS CAUSED BY THE DECISION OF THE PHYSICIAN TO CONTINUE WITH THE TREATMENT, DESPITE OF THE POOR VISIBILITY OF THE REGION OF INTEREST. TO ASSIST THE CUSTOMER PHILIPS CREATED A PROTOCOL SPECIFICALLY FOR VERTEBROPLASTY TO ACCOMMODATE THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED A CUSTOMER FEEDBACK IN WHICH THE CUSTOMER ALLEGED POOR IMAGE QUALITY DURING A SPINAL VERTEBROPLASTY PROCEDURE CAUSED AN INJURY. DOCTOR COULD NOT SEE THE FRONT WALL OF THE VERTEBRAL BODIES AND DID NOT SEE THE CEMENT DURING INJECTION. IT CAUSED A VENOUS LEAK WITH PULMONARY EMBOLISM AND A LEAK ROOT CANAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185500 ALLURA XPER FD20 ANGIOGRAPHIC X-RAY SYSTEM, SOLID X-RAY IMAGER OWB PHILIPS HEALTHCARE 722028

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other