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	Vascular Dissection (3160)
Date of Event	12/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device under evaluation.Upon completion of evaluation, a follow-up report will be submitted to fda.
Event or Problem Description
User facility reported: a female patient, age (b)(6), undergoing a coronary angio for a non-st-elevation myocardial infarction (nstemi), had a coronary dissection following coronary angio.Dissection occurred after the second injection into the right coronary artery (rca).Patient experienced chest pain of less than one hour in duration, st-segment elevation, and evidence of myocardial infarction.The patient recovered.Recovery date was not provided.
Additional Manufacturer Narrative
The acist angiographic injection system, model cvi, (b)(4), was returned to acist on 25 january 2018.The injector system was functionally tested and met the pre-established specifications.There was no evidence of device malfunction based on the data from the analysis of the injector system.The instructions for use have been reviewed and no inadequacies were identified with regard to warnings, contraindications, and the directions/conditions for the use of the device.User training was provided by the canadian importer's senior clinical specialist in november 2017 during device installation.On 31 january 2018 and 1 february 2018, the (b)(4) importer's senior clinical specialist visited the user facility for in-service follow-up training.Based on the investigation, there is no evidence of device malfunction related to this event and no inadequacies related to the device labeling/instructions for use or training.The cause of this 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: 7261503
• Report Number: 2134243-2018-00002
• Device Sequence Number: 16601034
• Product Code: DXT
• UDI-Device Identifier: 40841716101418
• UDI-Public: (01)40841716101418(11)170926
• 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: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2018

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: Physician
• Device Model Number: CVI
• Device Catalogue Number: 014657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2018
• Supplement Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 02/09/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 5FRENCH ALI DIAGNOSTIC CATHETER; ACETYLSALICYLIC ACID (ASA); CLOPIDOGREL; STATIN
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 47 YR
• Patient Weight: 140