MAUDE Adverse Event Report: ACIST MEDICAL SYSTEMS, INC. ACIST CVI® ANGIOGRAPHIC INJECTION SYSTEM INJECTOR HEAD; INJECTOR AND SYRINGE, ANGIOGRAPHIC

Model Number	014657
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Personnel in cardiac catheterization lab were cleaning room between cases, noted a smell and some smoke and a small line of "spark" and burn within the well of the syringe space was noted.The device was immediately unplugged.The device was not being used on a patient at the time of the incident.

• Brand Name: ACIST CVI® ANGIOGRAPHIC INJECTION SYSTEM INJECTOR HEAD
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): ACIST MEDICAL SYSTEMS, INC.; 7905 fuller road; eden prairie MN 55344
• MDR Report Key: 20332644
• Report Number: 20332644
• Device Sequence Number: 13159935
• Product Code: DXT
• UDI-Device Identifier: 10841716101233
• UDI-Public: (01)10841716101233
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2024
• Report Date (Section F): 06/26/2024

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
• Device Model Number: 014657
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/26/2024