MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS Q; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/06/2019

Event Type  malfunction  

Event Description

While performing an intracranial embolization the siemens artis q biplane had a failed roadmap.Scene 8 on accession number (b)(4), demonstrated the sophia intermediate catheter outside of the vessel wall when this was not the case.The road map did not line up with the live image.Clinical imaging was notified of the event.An additional run was performed to complete the procedure.Software version (b)(4).We were under the rm neuro old program.

• Brand Name: ARTIS Q
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; 40 liberty boulevard; mailcode: 65-1a; malvern PA 19355
• MDR Report Key: 9156084
• MDR Text Key: 161226888
• Report Number: 9156084
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/28/2019,08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/28/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27375 DA