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	07/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During a left heart catheterization (lhc) using the acist cvi contrast injection system, the right coronary artery (rca) was injected with contrast that showed stenosis.Subsequent injection of contrast was followed by air bubbles, causing the patient to become unresponsive.The patient had unequal pupils and right-side flaccidity.A stroke alert was called with a ct scan of the head performed.The patient was transferred to the intensive care unit and then to the university of kentucky hospital.The patient recovered after transport.
Additional Manufacturer Narrative
The acist angiographic injector, model cvi, 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 have been requested to be returned for evaluation.Upon return of the cine-angiograms, the clinical evaluation summary will be provided in a follow-up report.
Additional Manufacturer Narrative
On november 16, 2025, the acist medical advisory board member provided the following assessment after review of the information reported by the user facility: it appears that the observed air injection into the right coronary artery (rca) was temporally related to the observation of the patient becoming unresponsive.However, there was no information provided on the amount of air injected and whether there was any change in cardiac function in response to the air injection.Should additional information become available regarding this event, a follow-up report will be provided to the fda.This report is closed.

• 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: 22840221
• Report Number: 2134243-2025-00016
• Device Sequence Number: 11967740
• Product Code: DXT
• UDI-Device Identifier: 10841716101875
• UDI-Public: (01)10841716101875(11)200206
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

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: 07/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2020
• 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: ETOMIDATE FOR INTUBATION; FENTANYL; LIDOCAINE; RADIAL COCKTAIL-VERAPAMIL, NITROGLYCERINE, HEPARIN; VERSED; VISIPAQUE CONTRAST
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 88 KG