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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACIST MEDICAL SYSTEMS, INC. ACIST INJECTOR HEAD INJECTOR, CONTRAST MEDIUM

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ACIST MEDICAL SYSTEMS, INC. ACIST INJECTOR HEAD INJECTOR, CONTRAST MEDIUM Back to Search Results
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.
 
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Brand NameACIST INJECTOR HEAD
Type of DeviceINJECTOR, CONTRAST MEDIUM
Manufacturer (Section D)
ACIST MEDICAL SYSTEMS, INC.
eden prairie MN 55344
MDR Report Key7302639
MDR Text Key101346578
Report NumberMW5075582
Device Sequence Number2
Product Code IZQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
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 Received02/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/27/2018 Patient Sequence Number: 1
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