MAUDE Adverse Event Report: ACIST MEDICAL SYSTEMS, INC. ACIST; INJECTOR AND SYRINGE, ANGIOGRAPHIC, PRODUCT CODE:

Model Number CVI

Device Problems Air Leak (1008); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Air Embolism (1697)

Event Date 10/26/2017

Event Type  Injury  

Manufacturer Narrative

Device under evaluation.The evaluation will be provided in a follow-up report.

Event Description

During a heart cath procedure using the acist cvi injector, an air injection occurred.The air embolus was injected into the left ventricle.The air column detect message displayed on the injector.The patient experienced a duration of elevated st segment changes and recovered.

Manufacturer Narrative

The injection system was returned to acist and functionally tested and met the pre-established specifications.There was no evidence of device malfunction related to this event based on the data from the analysis of the injector.The consumables used in this case were not returned for evaluation and the lot numbers are not known.No device history record evaluation could be performed.The acist contrast injection system is equipped with an air column detect sensor.The air column detect sensor senses air in the proximal end of the high pressure (injection) tubing.If air is detected in the tubing, all fluid delivery functions are disabled.Per the acist cvi user manual, the air column detect sensor is designed to aid the user in the detection of air columns in the injection line, but it is not designed to replace the vigilance and care required of the operator in visually inspecting for air and clearing air from the entire patient kit and angiographic catheter.The air column detect mechanism is to be used in conjunction with and to complement the user's other procedures for preventing air injections.Acist's risk management has appropriate risk mitigations in place for potential air embolism due to user error, including labeling describing air bubble precautions and the user manual which guides the user through set-up and purge of the injector system.Based on the testing of the injector, there is no evidence of device malfunction related to this event.The cause of the event is inconclusive.This report is closed.File attachments.

• Brand Name: ACIST
• Type of Device: INJECTOR AND SYRINGE, ANGIOGRAPHIC, PRODUCT CODE:
• Manufacturer (Section D): ACIST MEDICAL SYSTEMS, INC.; 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
• MDR Report Key: 7039349
• MDR Text Key: 92299447
• Report Number: 2134243-2017-00016
• Device Sequence Number: 1
• Product Code: DXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CVI
• Device Catalogue Number: 014657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/13/2011
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 74 YR
• Patient Weight: 61