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	02/26/2024
Type of Reportable Event	Death
Event or Problem Description
User facility reported that the patient was in the cardiac cath lab for an out patient left heart cath procedure.Femoral access obtained by provider with 5fr sheath without complications.Left main selectively engaged.A test injection of approximately 2ml - 3ml of contrast was completed, and during this test injection, there was a sluggish flow in both the left anterior descending artery (lad) and circumflex arteries.The patient started experiencing chest pain immediately after the first injection, st elevation, bradycardia/asystole, and hypotension.Code blue was called.The patient expired after much efforts to resuscitate.Unknown cause for deterioration in patient's condition.Note: the person reporting the complaint stated that there were no air column detected message displayed by the cvi injection system and no air embolus reported.
Additional Manufacturer Narrative
D4: acist single-use manifold kit, model bt2000, lot 29823n; acist angiotouch hand controller kit, model at-p65, lot 32023f.H3: the acist angiographic injection system, model cvi, system serial number (b)(6), was received for evaluation on march 7, 2024.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 taken during the event will not be returned to acist.The consumable kits used during the event were discarded by the user facility, but the lot numbers were provided.The device history records of the consumables used during the event will be provided in a follow-up report.
Additional Manufacturer Narrative
A dhr review was conducted for the acist single-use manifold kit, model bt2000, lot 29823n; and acist angiotouch hand controller kit, model at-p65, lot 32023f.There were no quality issues or deviations during the manufacturing of these lots.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: 18991729
• Report Number: 2134243-2024-00005
• Device Sequence Number: 3089183
• Product Code: DXT
• UDI-Device Identifier: 40841716101876
• UDI-Public: (01)40841716101876(11)230830
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 03/26/2024

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
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2023
• 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 61%.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 65 KG