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

Model Number EMPOWER CTA+

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Air Embolism (1697)

Event Date 09/24/2022

Event Type  Death  

Event Description

During a computed tomography (ct) scan of the chest for pulmonary embolism, approximately 30 cc of air was injected into the patient.The patient experienced nausea, vomiting, chest pain, bradycardia, and a decline in mental status.An echocardiogram (ecg) revealed elevated st segments and the patient's blood pressure readings were as follows: 64/221, 45/121, and 123/74.There was evidence of myocardial infarction, specifically cardiac biomarker elevation.The air injection was first noticed thirty (30) minutes after the exam was completed.The patient expired on (b)(6) 2022.

Manufacturer Narrative

The empowercta+ injector, system serial number (b)(4) was returned to acist for evaluation on (b)(6) 2022.The cta+ injector was functionally tested and met the pre-established specifications.A review of the device history record of the empower cta+ injector serial number (b)(4) found no evidence of a device malfunction related to the reported event.Although requested from the user facility, the empowercta+ consumable kits and lot numbers used during the event were not provided to acist.Acist also requested copies of the images of the event, but these were not provided by the user facility to date.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.Per the empowercta+ users guide, "the empowercta+ injector system must be used properly to prevent the risk of an air embolism.Always fill the syringe with the injector pointing fully upward.When the syringe has been filled to the desired volume, all the air should be purged from the syringe and coiled tubing with the injector still in the fully vertical position.Failure to do so may lead to serious injury and/or death." based on testing and evaluation of the empowercta+ injection system, there was no evidence of device malfunction related to the reported event.

• Brand Name: EMPOWER CTA+
• Type of Device: INJECTOR, 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: teresa butler ; 7905 fuller road; eden prairie, MN 55344 ; 6125006492
• MDR Report Key: 15798223
• MDR Text Key: 303651121
• Report Number: 2134243-2022-00020
• Device Sequence Number: 1
• Product Code: IZQ
• UDI-Device Identifier: 47630039300904
• UDI-Public: (01)47630039300904(11)220701
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071378
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EMPOWER CTA+
• Device Catalogue Number: 017285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ALENDRONATE SODIUM 70MG; AVENTYL 75MG; COREG 6.25MG; FISH OIL 1200MG; IMDUR 50MG; LINSINOPRIL 20MG; LIPITOR 20MG; MAGNESIUM GLUCONATE 500MG; PRILOSEC 20MG; SOLIFENACIN SUCCINATE 10MG; TRAZODONE 150MG; ZANAFLEX 1MG
• Patient Outcome(s): Death
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 68 KG