MAUDE Adverse Event Report: PHILIPS IMAGE GUIDED THERAPY CORPORATION EAGLE EYE PLATINUM RX DIGITAL IVUS CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	85900P
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medical doctor stated that catheter was not working, only showing 1/4 of the vessel versus the full 360 view.

• Brand Name: EAGLE EYE PLATINUM RX DIGITAL IVUS CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS IMAGE GUIDED THERAPY CORPORATION; 5905 nathan lane north; plymouth MN 55442
• MDR Report Key: 22043845
• Report Number: 22043845
• Device Sequence Number: 9061297
• Product Code: OBJ
• UDI-Device Identifier: 00845225001278
• UDI-Public: (01)00845225001278(11)240210(17)260210(10)0303115414
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2025
• Report Date (Section F): 05/08/2025

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: 85900P
• Device Catalogue Number: 85900P
• Device Lot Number: 0303115414
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2025
• 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 Age: 65 YR
• Patient Sex: Female
• Patient Weight: 87 KG
• Date Report Sent to FDA: 05/08/2025