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

Model Number	CVI
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	06/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During a right and left heart catheterization using the acist cvi contrast injection system, after the user purged the consumable tubing of air and during the first injection, 6 cc of air was injected into the patient.The user noticed air bubbles in the consumable tubing that appeared to move backward away from the patient, towards the stopcock.The patient experienced chest pain, st segment elevation for a duration of five minutes, and hypotension.The physician administered epinephrine and flushed.The incident resolved quickly, and the patient recovered same day.
Additional Manufacturer Narrative
A2: patient age and birthdate is unknown.The age and birthdate is estimated.The acist angiographic injection system, model cvi, system serial number (b)(6), has not yet been returned to acist.The consumable kits used during the event were discarded by the user facility and the lot numbers are unknown.The cine-angiograms have been requested for evaluation, but will not be returned to acist.A follow-up report will be submitted to the fda upon completion of the investigation.
Additional Manufacturer Narrative
Correction to section c1 - isovue 370 contrast imaging bulk pack was listed on the medwatch report - initial as a suspect product.In this follow-up medwatch report, it has been updated to section d10 as a concomitant product.There is no indication of a causal relationship between the event and the isovue 370 contrast.The patient adverse clinical symptoms were due to air being injected into the patient during the angiography.The acist angiographic injection system, model cvi, system serial number (b)(6), was received for evaluation on (b)(6) 2024.The injection system was functionally tested and met the pre-established specifications.There was no evidence of device malfunction related to the reported event.The instructions for use have been reviewed and no inadequacies were identified regarding warnings, contraindications, and the directions/conditions for use of the device.Per the acist cvi user's 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.This report is closed.
Additional Manufacturer Narrative
The information provided by the user facility and the cineangiogram of the single angiographic run were reviewed by acist's medical advisory board member and is as follows: the information describes a large air injection that occurred on the first angiogram of the case.The user facility noted that the consumables were purged prior to the event.There was significant air still in the consumable tubing or catheter that was injected with the first injection of contrast.The source of the air cannot be determined, and clinical staff could not confirm if the cvi injector's air column detect sensor alerted the detection of air.It is possible that while the consumables where purged, the catheter was not completely emptied of air.The angiogram shows the outcome of the air injection with all left-sided vessels occluded.The patient appears to have been managed effectively with support and based on the information provided by the user facility, survived without significant sequela.This report is closed.

• Brand Name: ACIST
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• 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: teresa butler ; 7905 fuller road; eden prairie, MN 55344 ; 9529959300
• MDR Report Key: 19729844
• Report Number: 2134243-2024-00011
• Device Sequence Number: 15505815
• Product Code: DXT
• UDI-Device Identifier: 40841716101876
• UDI-Public: (01)40841716101876(11)210304
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K171646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CVI
• Device Catalogue Number: 014657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 09/11/2024; 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ISOVUE 370 CONTRAST BULK PACK.; ISOVUE 370 CONTRAST BULK PACK.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 70 YR
• Patient Sex: Female