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	05/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During the ivus ultrasound the images where very dark, and hard to see and eventually no longer visible.

• 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: 17583784
• Report Number: 17583784
• Device Sequence Number: 17404738
• 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): 05/17/2023
• Report Date (Section F): 05/17/2023

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: 03401117
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2023
• 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: Male
• Patient Weight: 122 KG
• Date Report Sent to FDA: 05/17/2023