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	12/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Acist has requested that the acist angiographic injection system, model cvi, serial number (b)(4), be sent to acist or investigation.Upon completion of the investigation, acist will submit a follow-up report to fda.
Event or Problem Description
After injecting into the left ventricle during a left ventricle catheterization procedure, the physician rinsed the high pressure tubing with saline to perform pressure measurements in the left ventricle and noted bubbles in the high pressure tubing.The patient experienced a transient ischemic attack (tia) during the procedure.A computed tomography (ct) scan was performed and the results confirmed no air was present in the patient's brain.The user facility notes they did not confirm air was injected into the patient during the catheterization procedure.
Additional Manufacturer Narrative
H3: the acist angiographic injection system, model cvi, serial number (b)(6), was returned to acist on 27 january 2020.The injector system was functionally tested and met the pre-established specifications.There was no evidence of device malfunction related to the reported event.The acist consumable kits used during the event were discarded by the user facility and the lot numbers are unknown; therefore, acist is unable to investigates these items.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.The cause of the event is inconclusive.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: 9645407
• Report Number: 2134243-2020-00001
• Device Sequence Number: 2783849
• Product Code: DXT
• UDI-Device Identifier: 40841716101418
• UDI-Public: (01)40841716101418(11)181114
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K010390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Initial Date Received by Manufacturer: 12/30/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 02/26/2020
• 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: 5000 UI HEPARIN; DIAGNOSTIC CATHETER; ISOPTIN; RISORDAN; 5000 UI HEPARIN; DIAGNOSTIC CATHETER; ISOPTIN; RISORDAN
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Age: 58 YR