MAUDE Adverse Event Report: ACIST MEDICAL SYSTEMS, INC. ACIST KODAMA® CORONARY IMAGING CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	017788
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Ultrasound catheter placed into coronary artery.As the catheter was pulling back, the catheter failed to provide image.Removed from body and provided a new ultrasound catheter was inserted into the coronary artery.

• Brand Name: ACIST KODAMA® CORONARY IMAGING CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): ACIST MEDICAL SYSTEMS, INC.; 7905 fuller road; eden prairie MN 55344
• MDR Report Key: 18038907
• Report Number: 18038907
• Device Sequence Number: 7429187
• Product Code: OBJ
• UDI-Device Identifier: 10841716100755
• UDI-Public: (01)10841716100755
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/28/2023
• Report Date (Section F): 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 017788
• Device Lot Number: 00325958
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 87 KG
• Date Report Sent to FDA: 06/28/2023