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	06/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The acist angiographic injection system, model cvi, injector serial number (b)(4), was received at acist for evaluation on july 20, 2021.The investigation has not yet started and will be included in a follow-up report to the fda.The consumable kits used during the event were discarded and the lot numbers are unknown.The cine-angiograms of the event are not available and were not returned to acist for evaluation.
Event or Problem Description
During a percutaneous coronary intervention for left anterior descending stenosis and using the acist angiographic injection system, model cvi, the user reported that just after the contrast injection into patient's left circumflex artery, air infusion was observed in the left anterior descending artery (lad).The patient's ecg showed st segment depression of unknown duration.The patient subsequently died on (b)(6) 2021.
Additional Manufacturer Narrative
H3: the acist angiographic injection system, model cvi, system serial number (b)(6), was received at acist for evaluation on july 4, 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.Based on the testing and evaluation of the cvi injection system, there was no evidence of device malfunction related to this event.This report is considered 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
• MDR Report Key: 12245791
• Report Number: 2134243-2021-00012
• Device Sequence Number: 2771826
• Product Code: DXT
• UDI-Device Identifier: 10841716101233
• UDI-Public: (01)10841716101233(11)17061
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2021

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?: Yes
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OMNIPAQUE 350 CONTRAST; PHILLIPS ALLURA CLARITY B12/12; OMNIPAQUE 350 CONTRAST; PHILLIPS ALLURA CLARITY B12/12
• Outcome Attributed to Adverse Event: Death; Hospitalization
• Patient Age: 70 YR
• Patient Weight: 60