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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACIST MEDICAL SYSTEMS EMPOWER CTA INJECTOR, CONTRAST MEDIUM, AUTOMATIC, PRODUCT CODE: IZQ

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ACIST MEDICAL SYSTEMS EMPOWER CTA INJECTOR, CONTRAST MEDIUM, AUTOMATIC, PRODUCT CODE: IZQ Back to Search Results
Model Number EMPOWER CTA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cardiac Arrest (1762)
Event Date 07/11/2021
Event Type  Death  
Manufacturer Narrative
The empowercta injection system, model cta, serial number (b)(4) was returned for evaluation on 13 july 2021. The injector system was functionally tested and met the pre-established specifications. A review of the device history was performed with no findings related to the reported complaint. There was no evidence of device malfunction related to the reported event. A copy of the ct procedure images and additional information on the event have been requested, but not yet provided. The consumable kits used during the event are not available for evaluation. The lot number of the empowerct syringe used during the event was provided and review of the device history records for this lot, 1866032008, was completed on 3 august 2021. There were no quality issues or deviations during the manufacturing of this lot related to the reported event. Upon completion of the evaluation of the requested information and/or images from the event, a follow-up mdr will be submitted to fda.
 
Event Description
The patient was admitted by an emergency physician on suspicion of cerebral infarction. Approximately 20 minutes after a computed tomography (ct) scan with an empowercta injection system, model cta, the patient went into cardiac arrest. The patient is deceased. The user facility considered that air may have been injected into the patient, but this was not conclusive.
 
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Brand NameEMPOWER CTA
Type of DeviceINJECTOR, CONTRAST MEDIUM, AUTOMATIC, PRODUCT CODE: IZQ
Manufacturer (Section D)
ACIST MEDICAL SYSTEMS
7905 fuller road
eden prairie MN 55344
Manufacturer (Section G)
ACIST MEDICAL SYSTEMS, INC.
7905 fuller road
eden prairie MN 55344
Manufacturer Contact
jeff audritsh
7905 fuller road
eden prairie, MN 55344
9529959347
MDR Report Key12306989
MDR Text Key266000025
Report Number2134243-2021-00011
Device Sequence Number1
Product Code IZQ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K071378
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberEMPOWER CTA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/08/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 08/11/2021 Patient Sequence Number: 1
Treatment
CTA CONNECTING TUBE, LOT IAQVJ-1903
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