MAUDE Adverse Event Report: ACIST ACIST CVI ANGIOGRAPHIC INJECTION; ACIST INJECTOR

Model Number	017738
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802)
Date of Event	07/13/2020
Type of Reportable Event	Death
Event or Problem Description
Diagnostic health cath utilizing acist medical device, immediately on initial injection of contrast, the pt experienced cardiopulmonary arrest.Unable to return spontaneous circulation and respirations.

• Brand Name: ACIST CVI ANGIOGRAPHIC INJECTION
• Common Device Name: ACIST INJECTOR
• Manufacturer (Section D): ACIST; 7905 fuller rd; eden prairie MN 55344
• MDR Report Key: 10351266
• Report Number: 10351266
• Device Sequence Number: 2330002
• Product Code: DXT
• UDI-Device Identifier: 10841716101196
• UDI-Public: 10841716101196
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/17/2020
• Report Date (Section F): 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/29/2020
• Device Model Number: 017738
• Distributor Facility Aware Date: 07/13/2020
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 61 YR
• Patient Weight: 147