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

Model Number	85900P
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Image from eagle eye ivus catheter would "flicker" and eventually went completely black.Catheter was exchanged for a new ivus catheter and the problem resolved.Manufacturer response for catheter, ultrasound, intravascular, eagle eye platinum digital ivus catheter (per site reporter).Looking into the problem.Asked for return of device for analysis.

• Brand Name: EAGLE EYE PLATINUM DIGITAL IVUS CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS IMAGE GUIDED THERAPY CORPORATION; 3721 valley centre drive; suite 500; san diego CA 92130
• MDR Report Key: 16673100
• Report Number: 16673100
• Device Sequence Number: 17447950
• Product Code: OBJ
• UDI-Device Identifier: 00845225001278
• UDI-Public: (01)00845225001278
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 03/27/2023
• Report Date (Section F): 03/27/2023

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: 85900P
• Device Catalogue Number: 85900P
• Device Lot Number: 0302844961
• 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: 04/04/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2023
• 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
• Date Report Sent to FDA: 03/27/2023