MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG ARTIS Q ZEEGO; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	10848283
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Codes	Renal Impairment (4499); Insufficient Information (4580)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the artis q zeego system.During an interventional procedure, a system malfunction and synchronization failure to the database occurred.Additional information was provided that a patient may have suffered an injury to the kidney.Detailed clarifications of this event are currently ongoing.Siemens has requested additional information in order to conduct an investigation of the reported event.
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed if additional information becomes available.
Additional Manufacturer Narrative
On (b)(6) 2024, a patient was treated for a chronic expanding aortic dissection.To prevent a tear in the aorta the implantation of a 4-fold fenestrated endoprosthesis, a very complex procedure, has been performed.In addition, a stent was planned in the left and right renal artery.The 4-fold fenestrated endoprosthesis and right kidney stent were placed without any problems.When cannulating the left renal artery, neither the image display with overlay function nor viewing of previous images was possible.After placement of the left renal artery, an early bifurcation was blocked.An impairment of the left kidney of 25% is estimated.According to the attending physician, the patient is fine, he did not notice this restriction.It is identified that the ivs application crashed.In this possible error case, the system automatically restarts the application, but this was not successful.This issue has been reported for the very first time.Despite extensive efforts, the cause of the issue identified could not be determined.The log file analysis did not reveal any indications of the root cause or the conditions when an automatic application restart is prevented.A manual restart of the system, which is also described in the user manual for such system behavior, was carried out by the user after the treatment, which then solved the issue.

• Brand Name: ARTIS Q ZEEGO
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 1-or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1- or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: jenna keefe ; 40 liberty blvd.; malvern, PA 19355 ; 4843234206
• MDR Report Key: 20278185
• Report Number: 3004977335-2024-00116
• Device Sequence Number: 8012798
• Product Code: OWB
• UDI-Device Identifier: 04056869010007
• UDI-Public: (01)04056869010007
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K181407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2024

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
• Operator of Device: Health Professional
• Device Model Number: 10848283
• Device Catalogue Number: 10848283
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 12/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown