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

Model Number 10848282

Device Problems Image Orientation Incorrect (1305); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Code Available (3191)

Event Date 01/10/2018

Event Type  malfunction  

Event Description

During an intracranial aneurysm coiling case in ipp 9 a 3d dsa spin was performed to evaluate the aneurysm pre treatment.The 3d was non-diagnostic and we see a large amount of artifact of unknown cause and filling defects.Patients head was taped, 3cc per second for a total of 21cc was injected via power injector.The patient was intubated with respirations held during the spin and was paralyzed.A second 3d was attempted with the same problem.The patient received an additional 21cc of contrast due to this failure with still non-diagnostic imaging.Manufacturer response for bi-plane, artis q (per site reporter): when siemens was working on the system the day before, it could be possible that they did not complete the qa portion for the 3d spin.They were contacted and this was completed.After this the 3d spin was working.

• Brand Name: ARTIS Q BIPLANE
• 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: 8270170
• MDR Text Key: 133860650
• Report Number: 8270170
• 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: 12/18/2018

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: 10848282
• 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: 12/18/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19345 DA