MAUDE Adverse Event Report: ACIST MEDICAL SYSTEMS, INC. ACIST; INJECTOR AND SYRINGE, ANGIOGRAPHIC

Model Number	CVI
Health Effect - Clinical Code	Death (1802)
Date of Event	12/20/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device evaluation will be provided in a follow-up report.
Event or Problem Description
User facility reported: a (b)(6) female patient was experiencing unstable angina and was undergoing a coronary angio.A coronary dissection occurred after injection into the right coronary artery (rca).The patient experienced shock, chest pain, st-segment elevation, ventricular fibrillation, hypotension, and myocardial infarction.The patient expired (b)(6) 2017.
Additional Manufacturer Narrative
The acist angiographic contrast injection system, model cvi, serial number (b)(4), was returned to acist on january 25, 2018.The injection system was functionally tested and met the pre-established specifications.There was no evidence of device malfunction related to this event based on the data from the analysis of the injector.The consumable kits used during the case were not returned for evaluation and the lot numbers are unknown.Based on the testing of the injector, there is no evidence of device malfunction related to this event.The cause of the event is inconclusive.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
• MDR Report Key: 7245334
• Report Number: 2134243-2018-00003
• Device Sequence Number: 933504
• Product Code: DXT
• UDI-Device Identifier: 10841716101233
• UDI-Public: (01)10841716101233(11)170915
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K010390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2018

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: 01/25/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/19/2018
• Supplement Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 02/06/2018
• Supplement Report FDA Received Date: 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 74 YR