MAUDE Adverse Event Report: CANON MEDICAL SYSTEMS CORPORATION CANON; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	INFX-8000V/ZP
Medical Device Problem Code	Inadequate User Interface (2958)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	04/25/2024
Type of Reportable Event	Death
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: CANON
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): CANON MEDICAL SYSTEMS CORPORATION; 1385 shimoishigami; otawara-shi, tochigi 324-8 550; JA 324-8550
• Manufacturer (Section G): CANON MEDICAL SYSTEMS CORPORATION; 1385 shimoishigami; otawara-shi, tochigi 324-8 550; JA 324-8550
• Manufacturer Contact: paul biggins ; 2441 michelle drive; tustin,, CA 92780 ; 7146697808
• MDR Report Key: 19534300
• Report Number: 2020563-2024-00005
• Device Sequence Number: 8541075
• Product Code: OWB
• UDI-Device Identifier: 04987670100222
• UDI-Public: (01)04987670100222
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K203551
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: INFX-8000V/ZP
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown