MAUDE Adverse Event Report: ACIST MEDICAL SYSTEMS, INC. ACIST POWER SUPPLY; ANGIOGRAPHIC INJECTION SYSTEM

Device Problem Insufficient Information (3190)

Patient Problems Air Embolism (1697); Chest Pain (1776); Myocardial Infarction (1969)

Event Date 02/16/2018

Event Type  Injury  

Event Description

Pt was at an outlying facility with complaints of chest pain.Pt was accepted to our facility for further treatment and evaluation of st elevation myocardial infarction.Cardiac cath team prepped the room for pt's arrival.The acist contrast injector was set up and primed in the normal process.Pt arrived to facility and was taken to the cath lab for an angiogram.Proceduralist obtained access through the right radial without difficulty.The catheter was inserted to the ascending aorta.The catheter was fully aspirated in standard fashion, contrast was advanced by acist device to the stopcock connected to the catheter and normal central aortic pressure wave was obtained.The tubing was filled with contrast and inspected in standard fashion, showing on air in tubing.The catheter was then flushed with contrast under fluoroscopy and advanced to the left main coronary ostium without difficulty with small test injections to guide engagement.Upon entering the left main, a small test injection (0.5 ml) done under fluoroscopy showed a poor flow in left coronary system.As pressure was on catheter was good, 4 ml injection of contrast was performed, showing evidence of air embolism in the lad and left circumflex artery.Pt coded and needed to be resuscitated with impella, amiodarone, intubation, defibrillation and temporary pacemaker.

• Brand Name: ACIST POWER SUPPLY
• Type of Device: ANGIOGRAPHIC INJECTION SYSTEM
• Manufacturer (Section D): ACIST MEDICAL SYSTEMS, INC.; eden prairie MN 55344
• MDR Report Key: 7302639
• MDR Text Key: 101346578
• Report Number: MW5075582
• Device Sequence Number: 1
• Product Code: DXT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/26/2018
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 97