MAUDE Adverse Event Report: BRACCO INJENEERING SA EMPOWER CTA+; INJECTOR, CONTRAST MEDIUM, AUTOMATIC

Model Number EMPOWER CTA+

Device Problem Use of Device Problem (1670)

Patient Problem Air Embolism (1697)

Event Date 08/21/2020

Event Type  Injury  

Manufacturer Narrative

Review of the device history record of the empower cta+ injector, serial number (b)(4), was completed and there were no deviations noted.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 information provided by the user facility, there was no indication of a device malfunction.The empower cta+ injector and associated consumable kits have been requested to be sent to the acist medical systems, inc.Service center for investigation.The devices have not been received by acist at the time of this report.A follow-up report will be submitted to fda upon completion of additional investigation.

Event Description

User facility reported that during an abdominopelvic computed tomography procedure using the empower cta+ injector, air was injected into the patient.No medical history, concomitant medications, allergies or prior use of contrast was reported.The ct procedure was completed by a retention nurse and was the last ct procedure the retention nurse performed that evening.Post the air injection, the patient had a stroke.The patient has been discharged from the hospital and has recovered; date of discharge not provided.The hospital safety committee spoke with the nurse and they have not been able to define what happened, but the suspected cause was user error.

Manufacturer Narrative

No evidence of device malfunction related to the reported event based on review of the device history records and information provided by the user facility.Although requested, the user facility elected not to return the injector system to acist for investigation and the consumables were discarded by the user facility.No additional information received on the event.

• Brand Name: EMPOWER CTA+
• Type of Device: INJECTOR, CONTRAST MEDIUM, AUTOMATIC
• Manufacturer (Section D): BRACCO INJENEERING SA; 46 avenue de sévelin; lausanne, vd 1004 ; SZ 1004
• MDR Report Key: 10578186
• MDR Text Key: 208302898
• Report Number: 3004753774-2020-00001
• Device Sequence Number: 1
• Product Code: IZQ
• Combination Product (y/n): N
• PMA/PMN Number: K071378
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• 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?: Yes
• Date Manufacturer Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening