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

Model Number AV11C

Device Problems Display or Visual Feedback Problem (1184); Malposition of Device (2616)

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

Event Date 12/20/2018

Event Type  malfunction  

Event Description

There were image quality issues with our imaging equipment located in neuro interventional radiology.Per dr., "the catheter appeared to be in the artery, but it was actually in the aneurysm.If continued to proceed with the procedure with the current acquired images; i would have ruptured the aneurysm and killed the patient".The pictures identify that the microcatheter is not in the aneurysm due to the black marker at the end of the microcatheter.The image shows a white distal marker that should not even exist; however, that was the true placement of the distal tip of the microcatheter.Physician was unable to identify true microcatheter placement unless visualized under a native live fluoro image.Risk to patient was significant.Manufacturer response for siemens artis av11c, (brand not provided) (per site reporter).We have had multiple issues with this particular room and siemens has not been able to fix it.We need this escalated up before someone dies.

• 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: 8284790
• MDR Text Key: 134332914
• Report Number: 8284790
• 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: 12/26/2018

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
• Device Model Number: AV11C
• 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: 12/26/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/29/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25550 DA