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	10/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During a cardiac catheterization, the tip of a acist medical ivus catheter dislodged and was seen on fluoro.Catheter was removed and the tip was retrieved with no harm to patient.Second catheter was used without incident.

• 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: 15759409
• Report Number: 15759409
• Device Sequence Number: 20421308
• 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): 10/17/2022
• Report Date (Section F): 10/17/2022

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
• Device Model Number: 017788
• Device Lot Number: 0030482
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/17/2022