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	03/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The acist angiographic injection system, model cvi, system (b)(4) has not yet been returned to acist for evaluation.The cine-angiograms of the event were received by acist and are being reviewed by acist's medical advisor.The consumables kits used during the event were discarded by the user facility and the lot numbers are unknown.Upon completion of the investigation, a follow-up report will be submitted to fda.
Event or Problem Description
User facility reported that a (b)(6) male with non-st-elevation myocardial infarction (nstemi) was taken to the cath lab for left heart catheterization (lhc) with percutaneous coronary intervention (pci).Acist angiographic injection system, model cvi was used for contrast injections.Upon the sixth injection of contrast into the patient, air was visible within the left anterior descending artery (lad).The patient experienced acute chronic chest pain for 1-2 minutes post injection and blood pressure < 90 mmhg systolic.The patient tolerated the air injection with no deterioration in clinical condition.
Additional Manufacturer Narrative
H3: the acist angiographic injection system, model cvi, injector serial number (b)(6) was returned on april 25, 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.A clinical evaluation was completed on may 16, 2022.The clinical evaluation by the acist medical advisory board member is as follows: the information provided by the user facility reports that a single bubble was injected into the patient on the sixth injection.The angiographic films show a left coronary injection with a single bubble injected.This size of air injection is generally tolerated well and this is consistent with the report of no apparent harm.The air does not appear to impact contrast flow during this injection and flow also appears normal on the next injection.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: 14218923
• Report Number: 2134243-2022-00007
• Device Sequence Number: 14506389
• Product Code: DXT
• UDI-Device Identifier: 10841716101233
• UDI-Public: (01)10841716101233(11)180918
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2018
• 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: ANGIODYNAMICS 0.35X260 DIAGNOSTIC WIRE; CARDENE; FENTANYL; HEPARIN; LIDOCAINE; MEDTRONIC 5 FR PIGTAIL CATHETER; MEDTRONIC EUPHORA 2.0X12MM BALLOON; MEDTRONIC EUPHORA 3.5X15 BALLOON; MEDTRONIC EUPHORA 4.0X15 BALLOON; MEDTRONIC JL 3.5 DEXTERITY CATHETER LOT 6031447; MEDTRONIC JR 4 DEXTERITY CATHETER LOT 601298902001; MEDTRONIC LAUNCHER 6 FR JR 4 GUIDE CATHETER; MEDTRONIC RESOLUTE ONYX 3.5X22 STENT; TICAGRELOR; VOLCANO IVUS EAGLE EYE PLATINUM CATHETER
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 102 KG