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	09/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The acist angiographic injection system, model cvi, serial number (b)(4) has not yet been returned for evaluation.The consumable kits used during the event were discarded and the lot numbers are not known.The injector system, cables, cine-angiograms and additional information were requested to be returned to acist for evaluation.
Event or Problem Description
After 40 minutes in to a left heart catheter coronary intervention, small air bubbles (approximately 3cc) were injected into a patient.The patient experienced blood pressure <90 mmhg systolic.The patient recovered the same day.
Additional Manufacturer Narrative
H3: the acist angiographic injection system, model cvi, system serial number (b)(6) was returned on (b)(6) 2021.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.The cine-angiograms will not be provided by the user facility for clinical assessment.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; 7905 fuller road; eden prairie MN 55344
• Manufacturer Contact: jeff audritsh ; 7905 fuller road; eden prairie, MN 55344 ; 9529959347
• MDR Report Key: 12628981
• Report Number: 2134243-2021-00019
• Device Sequence Number: 14525575
• Product Code: DXT
• UDI-Device Identifier: 10841716101875
• UDI-Public: (01)10841716101875(11)191218
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: K103090
• 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): 09/13/2021

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2020
• 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: VISIPAQUE 320 CONTRAST; VISIPAQUE 320 CONTRAST
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 59 KG