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

Model Number INFX-8000V

Device Problem Human-Device Interface Problem (2949)

Patient Problem Ruptured Aneurysm (4436)

Event Date 11/18/2023

Event Type  Injury  

Manufacturer Narrative

As a result of the log investigation, the device operation worked fine at the event.Image data was analyzed by cmsc and is was confirmed that the measurements were within the measurement error.As a result it is believed that the incident was caused by the user's decision on the coil size and not related to the system measurements.

Event Description

The doctor used the measurement function of the device to measure the size of the very small aneurysm.The doctor determined the size of the coil, and began performing the procedure, but determined the size might be larger as a result, rupture of the aneurysm occurred.After that, a smaller coil was used and the procedure was terminated as bleeding stopped.

• Brand Name: CANON
• Type of Device: 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: 18322850
• MDR Text Key: 330427866
• Report Number: 2020563-2023-00006
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: MY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: INFX-8000V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other