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

Model Number	ACIST
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	01/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The acist angiographic injection system, model cvi, system serial number (b)(4), was returned on (b)(6) 2022.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 the 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.No consumables were returned for evaluation and the lot numbers are not known.If available, the clinical assessment for the cine-angiograms will be included in the follow-up report.Note: this event was reported to acist on (b)(6) 2022 with no reports of patient injury.Additional information on the event, including adverse patient effects, was received (b)(6) 2022.
Event or Problem Description
During the first injection of contrast into the patient during a cardiac angiogram for unstable angina, the physician noticed that something looked off in the images.On the second injection of contrast into the patient, the patient's blood pressure dropped to 60 mmhg systolic and ekg changes were noted.The patient did not complain of any pain, but the patient was also sedated during the procedure.The physician was concerned at this time that the patient's vessels were spasming or there was a suspected air bubble in the vessel.After reviewing the images, the physician saw what appeared to be bubbles going down the left anterior descending and left circumflex arteries.There were no bubbles seen on repeat images taken of the left coronary system.The patient's condition started to improve within ten minutes of the initial contrast injections.No interventions were needed to support the patient during this event, and the patient recovered the same day.
Additional Manufacturer Narrative
A review of the information provided by the user facility was completed by acist's medical advisor on april 2, 2022.No cineangiograms were available for review.The user facility described an event during a patient angiogram.The state of the patient was found to be hypotensive at time of the second contrast injection.The user facility also stated that they had difficulty with the injector set up and prep, and that after review of the fluoro images, they recognized that air had been injected and that presumably this was the cause of the patient's hypotension.Without more information and a copy of the cineangiograms of the event, it is difficult to judge if in fact the air injection was the cause of the hypotension, the quantity of air that was injected, or what exactly was seen on fluoro to lead them to the conclusion that air was injected.This report is closed.

• Brand Name: ACIST
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC:
• Manufacturer (Section D): ACIST MEDICAL SYSTEMS; 7905 fuller road; eden prairie MN 55344
• Manufacturer (Section G): ACIST MEDICAL SYSTEMS; 7905 fuller road; eden prairie MN 55344
• Manufacturer Contact: jeff audritsh ; 7905 fuller road; eden prairie, MN 55344 ; 9529959347
• MDR Report Key: 13638809
• Report Number: 2134243-2022-00004
• Device Sequence Number: 20093547
• Product Code: DXT
• UDI-Device Identifier: 40841716101883
• UDI-Public: (01)40841716101883(11)201215
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/01/2022

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: ACIST
• Device Catalogue Number: 014657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2020
• 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: AMARYL; ASPIRIN; CALCIUM AND VIT D; GABAPENTIN; LANTUS; LIPITOR; LOSARTAN; METFORMIN; MULTIVITAMIN; NAPROXEN; OMNIPAQUE; TRULICITY; ZOFRAN
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 111 KG