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	08/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The consumables used during the event were the at-p65 hand controller lot# 11121g, a2000 syringe lot# 11121t and bt2000 manifold lot # 35020u.The acist angiographic injection system, model cvi, system serial number (b)(4) was received august 31, 2021, and investigation is in process.The consumables used during the event were discarded by the user facility.The device history record of the lot numbers will be evaluated.The cine-angiograms images were requested for clinical assessment.The results of the investigation will be included in a follow-up report.
Event or Problem Description
At the start of a coronary angiography procedure of a (b)(6)year old male, it was noticed that there was approximately 10 ml of air in the right coronary artery (rca) and left anterior descending artery (lad).The patient experienced chest pain for a duration of ten minutes, st segment elevation, bradycardia, and blood pressure < 90 mmhg systolic.The patient recovered the same day.
Additional Manufacturer Narrative
H3: review of the device history record was completed on september 22, 2021, for the following cvi consumable kit lots used during the event, the acist manifold kit, model bt2000, lot 35020u; acist hand controller model at-p65, lot 11121g, acist syringe model a2000, lot 11121t.This review confirmed that there were no quality issues during the manufacturing of these lots related to the reported event.The kits were discarded by the user facility after the event.The acist angiographic injection system, model cvi, system serial number 30001847, was received at acist for evaluation on september 9, 2021.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 the use of the device.Based on the testing and evaluation of the cvi injection system, there was no evidence of device malfunction related to this event.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.

• Brand Name: ACIST
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): ACIST MEDICAL SYSTEMS, INC.; 7905 fuller road; eden prairie MN 55344
• MDR Report Key: 12467162
• Report Number: 2134243-2021-00016
• Device Sequence Number: 14408266
• Product Code: DXT
• UDI-Device Identifier: 10841716101233
• UDI-Public: (01)10841716101233(11)161109
• Combination Product (Y/N): Y
• Initial Reporter Country: TC
• PMA/510(K) Number: K010390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2021

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
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN 100 MG; PLENICA 15 MG; VISIPAQUE CONTRAST; ASPIRIN 100 MG; PLENICA 15 MG; VISIPAQUE CONTRAST
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Age: 66 YR
• Patient Weight: 72