MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS Q BIPLANE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 10848282

Device Problem Poor Quality Image (1408)

Patient Problem Perforation (2001)

Event Date 10/30/2023

Event Type  Injury  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported event.

Event Description

Siemens became aware of an incident that occurred while operating the artis q biplane system.During an interventional procedure for device implantation, the displayed digital subtraction angiography (dsa) roadmap was very hazy with no vessel borders visible to the user.The issue occurred during dilation of the coronary artery.According to the additionally provided information, the images looked as there was a lot of movement, though the patient was under general anesthesia unable to move.Multiple cines were repeated with contrast; however, this did not improve image quality.The user continued the procedure despite the poor image quality.Siemens was informed that a cerebral aneurysm perforation by wire had occurred during this procedure.On (b)(6) 2023, additional information was provided to siemens stating that the patient passed away.

Manufacturer Narrative

Siemens healthineers has conducted a technical and clinical investigation of the reported event by a dedicated team to analyze the case consisting of technical, clinical, risk and quality experts.The event logs and x-ray data have been analyzed.No issues with the x-ray data for both digital subtraction angiography (dsa) and dsa roadmap could be identified.It was confirmed that the concerned system was functioning according to specifications as no software errors or other technical aspects pointing to system malfunction were found.The artis q biplane system is equipped with the motion correction setting.The investigation revealed that the motion correction had not been activated by the operator during the procedure to prevent dsa roadmap motion artifacts.It was concluded by the clinical experts that the dsa roadmap functioned properly as it is normal to see motion artifacts as subtraction artifacts on the system with motion correction functionality not present.In addition, motion artifacts are typical during neuro-interventional procedures.According to expert opinion, in the reported case the patient¿s head movements could be seen on the provided images and were the cause of the subtraction artifacts.The movements were hardly visible in the native images.However, even small movements induce subtraction-artifacts, which were clearly visible in the roadmap.In postprocessing, the subtraction artifacts can be significantly reduced with manual pixel shift.This information is provided to the user with the artis q/zeego/q.Zen operator manual ax4-100.620.20.02.02.The operator manual also provides various means on how to reduce motion artifacts such as proper head fixation, roadmap reset option, etc.A siemens healthineers team of technical and clinical experts concluded that the image quality was acceptable from a technical and clinical point of view and the system worked as specified.The available data gives no evidence either to conclude a causal relationship between an alleged image quality issue and a vessel perforation nor between the alleged iatrogenic aneurysm perforation and the patient¿s clinical development after the intervention.It cannot be excluded that the amount of motion artifacts may have contributed to an iatrogenic vessel perforation.However, this could have been resolved by the interventionalist via various available means, enhancements and functionalities listed above.A dedicated failure mode of the system or a failure of a component of the system could not be identified.This case is a single event and neither a general nor systematic problem has been recognized.

• Brand Name: ARTIS Q BIPLANE
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemenstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 18112241
• MDR Text Key: 327864539
• Report Number: 3004977335-2023-00149
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869009995
• UDI-Public: 04056869009995
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K181407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10848282
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Female