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	05/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Upon completion of the investigation, acist will submit the follow-up report.The cine-angiograms have not been returned for evaluation.The acist medical advisory board member' reviewed the information provided by the user facility and this assessment is as follows: no angiographic images were provided.The report provided by the user facility describes a significant air injection that occurred with initial cannulation of the left main artery.The report states that they felt the air injection was due to user error.This is consistent with the information provided.Namely, that the air was apparently injected as the catheter was initially being filled prior to the first angiographic image.In this circumstance, the source of the air is usually from incomplete evacuation of air form the catheter or tuohy.It appears that the staff successfully resuscitated the patient without permanent damage with a good outcome per their report.
Event or Problem Description
During a left heart catheterization for cardiomyopathy and acute heart failure, air was injected into a patient.Following radial sheath prep for spasm prophylaxis, a 5 french jl3.5 catheter was taken over a j-wire and used to engage the left main ostium for left coronary angiography.The catheter was flushed twice per standard process using 10cc syringes; there was no air alert message displayed by the cvi injection system.A subsequent test injection was completed to confirm engagement of the left main.There was significant air embolism into the circumflex and the left anterior descending artery (lad), along the mid circumflex and mid lad with no flow in the distal vessels seen.An initial quick attempt to aspirate through the jl 3.5 diagnostic catheter was unsuccessful.The patient quickly deteriorated, became bradycardic, and was given 1 mg of atropine.The patient became unresponsive and an emergent airway was called; he was intubated.The patient subsequently went into pulseless electrical activity (pea) arrest and cardiopulmonary resuscitation (cpr) was initiated.After one round of cpr and 1 mg of epinephrine (epi), there was return of spontaneous circulation (rosc).The user facility stated that the air injection was due to user error.
Additional Manufacturer Narrative
The acist angiographic injection system, model cvi, system serial number (b)(6), was received for evaluation on july 10, 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: 22588983
• Report Number: 2134243-2025-00014
• Device Sequence Number: 9128814
• Product Code: DXT
• UDI-Device Identifier: 40841716101418
• UDI-Public: 40841716101418
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 07/23/2025

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: 06/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2016
• 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 300.
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Age: 50 YR
• Patient Sex: Male