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

Model Number	CVI
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	11/27/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
The acist angiographic injection system, model cvi, system serial number (b)(6), has not yet been returned to acist.The consumable kits used during the event were discarded by the user facility and the lot numbers are unknown.The cine-angiograms have been requested for evaluation but have not yet been returned to acist.A clinical assessment by an acist medical advisory board member will be performed on the cine-angiograms upon receipt.A follow-up report will be submitted to fda upon completion of the investigation.
Event or Problem Description
During a percutaneous coronary intervention using the acist cvi injection system, air was injected into a patient.The air injection occurred after insertion of a coronary guiding catheter and engagement into the left main coronary artery and upon injection of contrast media.The patient experienced cardiogenic crash and shock and expired the same day.
Additional Manufacturer Narrative
The acist angiographic injection system, model cvi, system serial number (b)(6), was received for evaluation on february 4, 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: 21203140
• Report Number: 2134243-2025-00001
• Device Sequence Number: 8080760
• Product Code: DXT
• UDI-Device Identifier: 40841716101425
• UDI-Public: 40841716101425
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2025

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: 12/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2014
• 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: Hospitalization; Death
• Patient Age: 59 YR
• Patient Sex: Male