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	02/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The acist angiographic injection system, model cvi, serial number (b)(4) was returned to acist on march 27, 2023, but has not yet been evaluated.The consumables used during the event were discarded by your facility and the lot numbers are not known.The cine-angiograms taken during the event 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 the fda upon completion of the clinical assessment of the cine-angiograms assessment and completion of the investigation.
Event or Problem Description
During a left heart catheterization (lad) for coronary artery disease (cad) on a 73-year-old female patient, air bubbles were injected into the patient's right coronary artery (rca); column of air with no flow past the proximal segment.Patient experienced blood pressure of less than < 90 mmhg systolic, st-segment elevation on the ekg, hypoxia, and chest pain.The patient was administered heparin, neosynephrine / levophed, and placed on oxygen.Guidewire introduced to rca, pronto thrombectomy cath performed, and patient was given a dose of nitroglycerin and intracoronary adenosine.The repeat angiogram showed restoration of flow and the patient's symptoms subsided.The patient subsequently recovered.
Additional Manufacturer Narrative
The acist angiographic injection system, model cvi, system serial number (b)(6), was evaluated april 25, 2023.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.The cine-angiograms were evaluated by the acist medical advisory board member and is as follows: i reviewed the report and angio films, and, as described, the angio shows a first image of an occluded right coronary artery (rca) that is consistent with a significant amount of air having been injected into the vessel prior to this angio image.This was the first image of the angio.Presumably, the air was not fully evacuated from the system during set up or air was not fully cleared from the tuohy/catheter.This air was likely injected during filling of catheter with contrast.It was cleared with aspiration.Subsequently, angiography of the left coronary was completed without incident.The customer reported that the facility's lead angiography technologist had received refresher training in set up, flushing and best practices.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: 16743005
• Report Number: 2134243-2023-00006
• Device Sequence Number: 5377968
• Product Code: DXT
• UDI-Device Identifier: 40841716101876
• UDI-Public: (01)40841716101876(11)210830
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2023

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: 03/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2021
• 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: HEPARIN.; IC ADENOSINE.; NITROGLYCERIN (NTG).; PROCEDURAL SEDATION.; VERAPAMIL.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 88 KG