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	02/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During a cardiac catheterization for a patient presenting with chest pain, six minutes after the start of the procedure, air was injected into the patient's right coronary artery (rca).The patient experienced hypotension and ventricular fibrillation.The patient was stable after defibrillation performed.
Additional Manufacturer Narrative
The acist angiographic injection system, model: cvi, serial number: (b)(6) was requested by acist but 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.The acist medical advisory board member provided the following clinical assessment: the report describes an air injection in the right coronary artery, followed by ventricular fibrillation that responded to defibrillation shock.It is difficult to draw further conclusions based on the report alone.Although the injection was midway through the case, it was an injection in the right coronary artery (rca).So, it is possible that this was the first injection through the rca catheter, which increases the likelihood that the air came from incompletely evacuated air of the catheter or tubing/tuohy.The amount of air injected is also not described.If only a single bubble was injected, this is less likely to be the cause of the ventricular fibrillation.If the cine-angiograms become available, further medical assessment will be provided.Upon completion of the investigation, acist will submit the follow-up report.
Additional Manufacturer Narrative
The acist angiographic injection system, model cvi, system serial number (b)(6), was received for evaluation on april 8, 2025.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.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: 21692376
• Report Number: 2134243-2025-00008
• Device Sequence Number: 9234141
• Product Code: DXT
• UDI-Device Identifier: 40841716101876
• UDI-Public: (01)40841716101876(11)23121
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/21/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2023
• 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: ASA.; CRESTOR.; IMDUR.; ISOVUE 370 100 ML SINGLE DOSE.; LASIX.; LOPRESSOR.; NORVASC.; PLAVIX.; RANEXA.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 82 KG