MAUDE Adverse Event Report: ACIST MEDICAL SYSTEMS, INC. ACIST; INJECTOR AND SYRINGE, ANGIOGRAPHIC

Model Number	CVI
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	06/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2: no patient information provided.The patient date of birth is not known and is estimated.The acist angiographic injection system, model cvi, serial number (b)(6) has not yet been returned to acist.The consumables used during the event were discarded by the user facility and the lot numbers are not known.The cine-angiograms have not been returned for evaluation.Upon completion of the investigation, acist will submit a follow-up report.
Event or Problem Description
During a coronary angiography, a student doctor injected air into the patient upon the last injection of contrast media.The patient flatlined for 30 seconds, after which the patient became responsive and was aware.According to the user facility, the air injection was due to user error.The user facility reported that they have a cine-angiogram of the procedure they will email to acist.

• Brand Name: ACIST
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): ACIST MEDICAL SYSTEMS, INC.; 7905 fuller road; eden prairie MN 55344
• Manufacturer (Section G): ACIST MEDICAL SYSTEMS, INC.; 7905 fuller road; eden prairie MN 55344
• Manufacturer Contact: teresa butler ; 7905 fuller road; eden prairie, MN 55344 ; 9529959300
• MDR Report Key: 22512245
• Report Number: 2134243-2025-00012
• Device Sequence Number: 21157990
• Product Code: DXT
• UDI-Device Identifier: 10841716101875
• UDI-Public: (01)10841716101875(11)190520
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K010390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CVI
• Device Catalogue Number: 014657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2019
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Unknown