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

Device Problems Poor Quality Image (1408); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 04/18/2019

Event Type  malfunction  

Event Description

Version # (b)(4).While performing a routine cerebral angiogram in ipp 9, 3 separate errors occurred requiring additional injections of omnipaque 300 and radiation to the patient.The 3d spin processed very blurry and nearly non-diagnostic.A failed dsa run occurred on run 14 in the a plane.This occurred during a biplane injection and only the b plane was acquired.The a plane stated "x-ray unavailable".When performing a bilateral biplane road map there is a significant delay between the a plane and b plane becoming active, this has led to several repeat roadmaps.Manufacturer response for artis q biplane, artis q, (per site reporter).Ongoing discussion and attempts at resolution of this issue.

• 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: 8716153
• MDR Text Key: 148636056
• Report Number: 8716153
• 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: 04/18/2019

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: 04/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/20/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22630 DA