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

Model Number CVI

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 02/21/2019

Event Type  Death  

Manufacturer Narrative

Acist angiographic injection system, model cvi, serial number (b)(4) was received at acist on march 14, 2019.Investigation is in process.Upon completion of the investigation, acist will submit a followup report to fda.

Event Description

User facility reported, during a diagnostic catheterization of a patient with non-st-elevation myocardial infarction, upon injection of contrast media using the acist cvi injector, dissection of a patient's left internal mammary artery (lima) occurred.Upon the first selective shot, there was no dissection.The jr4 5fr catheter dislodged and could not re-engage.A non-selective shot revealed the lima dissection.The patient experienced chest pain, st-segment depression, hypotension, and myocardial infarction.The dissection was stented.The patient subsequently died the same day.

Manufacturer Narrative

Hthe acist angiographic injection system, model cvi, serial number (b)(4), was returned to acist on (b)(6) 2019.The injector system was functionally tested and met the pre-established specifications.Acist requested a copy of the cineangiograms to review as part of the investigation but the user facility elected not to provide this item.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 regarding warnings, contraindications, and the directions/conditions for the use of the device.Based on this investigation, there is no evidence of device malfunction related to this event and no inadequacies related to the device labeling/instructions for use.The cause of the event is unknown.This report is considered closed.

• Brand Name: ACIST
• Type of Device: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): ACIST MEDICAL SYSTEMS, INC.; 7905 fuller road; eden prairie MN 55344
• MDR Report Key: 8467963
• MDR Text Key: 140419305
• Report Number: 2134243-2019-00004
• Device Sequence Number: 1
• Product Code: DXT
• Combination Product (y/n): N
• PMA/PMN Number: K010390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CVI
• Device Catalogue Number: 014657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Date Manufacturer Received: 03/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BOSTON SCIENTIFIC JR4 EXPO CATHETER
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Weight: 78