BEUDAMED
    FDA Adverse Event Death Summary report: N

    CANON

    MDR report key: 19534300 · Received June 13, 2024

    Report

    Report Number
    2020563-2024-00005
    Event Type
    Death
    Date Received
    June 13, 2024
    Date of Event
    April 25, 2024
    Report Date
    June 11, 2024
    Manufacturer
    CANON MEDICAL SYSTEMS CORPORATION
    Product Code
    OWB
    UDI-DI
    04987670100222
    PMA / PMN Number
    K203551
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN INSPECTION OF THE SYSTEM LOG FILES AND RECORDED IMAGES BY THE MANUFACTURER FOUND THAT: - THERE WERE AT LEAST TWO DSA IMAGES THAT INDICATED POTENTIAL BLEEDING FROM THE ANEURYSM (AROUND 11:47 AND 12:50) - THERE WAS AT LEAST ONE FLUOROSCOPIC IMAGE THAT INDICATED ACCIDENTAL PENETRATION OF THE ANEURYSM BY THE INTERVENTIONAL DEVICE (12:40). - THERE WAS NO EVIDENCE OF ANY SYSTEM MALFUNCTION OR ERRORS DURING THE STUDY IN THE LOG FILES. - THE RECORDED FLUOROSCOPIC AND DSA IMAGES WERE OF MAGNIFIED 4.3" FOV BUT THE IMAGE QUALITY WAS NORMAL, AS EVIDENCED BY THE DEVICES BEING CLEARLY VISIBLE, AND CONTRAST OF THE VESSELS WERE FAIR. IMAGES DID NOT APPEAR TO SUFFER SIGNIFICANT DEGRADATION AS STATED BY THE CUSTOMER DURING THE BLEEDING AND PENETRATION. - THE MANUFACTURER WAS UNABLE TO ESTABLISH A DIRECT CONNECTION BETWEEN THE DSA IMAGE AND THE INCIDENT, AS THE IMAGE WAS TAKEN AFTER ABOVE-MENTIONED BLEEDING AND PENETRATION.

    Description of Event or Problem · 0

    IN A HOSPITAL, LOCATED IN SPAIN, ON (B)(6) 2024 IT WAS ALLEGED BY THE USER THAT "IMAGE DEFINITION IS LOST WHEN MAGNIFYING, THIS PREVENTS THE CORRECT VISUALIZATION OF THE CATHETER NAVIGATION USING FLUORO AND ALSO PREVENTS THE CORRECT RELEASE OF THE STENTS OR FLOW DIVERTER DEVICES. ALSO, THE GRAIN OF THE IMAGE AND THE HALO EFFECT AROUND THE COILS ARE PRONOUNCED". THE PATIENT FROM (B)(6) ALLEGEDLY SUFFERED A PERFORATION DURING THE PROCEDURE THAT RESULTED IN SEVERE BLEEDING. THE MANUFACTURED RECEIVED INFORMED ON MAY 22ND THAT THE PATIENT HAD PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157667 CANON INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB CANON MEDICAL SYSTEMS CORPORATION INFX-8000V/ZP 04987670100222

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death