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

Device Problems Material Perforation (2205); Material Protrusion/Extrusion (2979)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 12/12/2018

Event Type  malfunction  

Event Description

During an intracranial coiling in ipp 9 the roadmap on run 6 demonstrated that the micro wire was protruding outside of the vessel wall, indicating a perforation.An additional run was performed to check the validity of the wire location.The additional run demonstrated that the wire was not extravascular and was in adequate location.This same occurrence occurred one more time during the case, requiring another additional run.Patient received an additional 20cc of omnipaque 300 and radiation exposure due to this problem.

• 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: 8270278
• MDR Text Key: 133845542
• Report Number: 8270278
• 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: 12/13/2018

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
• 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: 12/13/2018
• 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: 15695 DA