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	10/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2: no patient information.Age estimated.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.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 investigation.
Event or Problem Description
User reported when finishing the case, upon review of the images, a large amount of air was observed.The patient coded and was revived.Additional information regarding the event has been requested.
Additional Manufacturer Narrative
The acist angiographic injection system, model cvi, system serial number (b)(6), was returned for evaluation november 27, 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.In addition, support personnel must ensure that: all system connections are in place, secure, and functional.The cine-angiograms were not returned for evaluation.A follow-up report will be submitted if the cine-angiograms are returned for evaluation.This report is closed.
Event or Problem Description
Additional information: the reason for the angiographic procedure was due to ejection fraction (ef) drop.After patient coded, the patient was intubated, put on a ventilator and transferred to icu.

• 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: 18209037
• Report Number: 2134243-2023-00012
• Device Sequence Number: 12612896
• Product Code: DXT
• UDI-Device Identifier: 10841716101875
• UDI-Public: (01)10841716101875(11)190522
• 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): 11/20/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2019
• 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: OPTIRAY 370 CONTRAST.
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 40 KG