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	02/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The acist angiographic injection system, model cvi, system serial number (b)(6), was returned to acist on (b)(6) 2025.The consumable kits used during the event were discarded by the user facility and the lot numbers are unknown.The injection system was functionally tested and met the pre-established specifications.There was no evidence of device malfunction related to the reported event.The instructions for use have been reviewed and no inadequacies were identified regarding warnings, contraindications, and the directions/conditions for use of the device.Per the acist cvi user's manual, the air column detect sensor is designed to aid the user in the detection of air columns in the injection line, but it is not designed to replace the vigilance and care required of the operator in visually inspecting for air and clearing air from the entire patient kit and angiographic catheter.The air column detect mechanism is to be used in conjunction with and to complement the user's other procedures for preventing air injections.In addition, support personnel must ensure that: all system connections are in place, secure, and functional.The cine-angiograms will not be returned for evaluation.This report is closed.
Event or Problem Description
During an angiography using the acist injection system, model cvi, upon the first injection of contrast media into the left coronary artery, approximately 5cc of air was injected into the patient's artery.The patient experienced st segment elevation for a duration of 47 seconds and the patient's heart rate decreased.The patient recovered the same day.

• 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: 21594170
• Report Number: 2134243-2025-00005
• Device Sequence Number: 8265673
• Product Code: DXT
• UDI-Device Identifier: 40841716101883
• UDI-Public: (01)40841716101883(11)220505
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 03/11/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ISOVUE 370 CONTRAST; MEDTRONIC JL 4.0 GUIDE CATHETER
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 52 KG