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

Model Number 85900P

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 11/11/2022

Event Type  malfunction  

Event Description

Pim (patient interface module) error (ivus unplugged/plugged back in) pim error resolved but showed catheter error.Shut down ivus, but still showing catheter error.New ivus was used.Reported to mfg rga issued # (b)(4).

• Brand Name: EAGLE EYE PLATINUM DIGITAL IVUS CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS IMAGE GUIDED THERAPY CORPORATION; 3721 valley centre dr ste 500; san diego CA 92130
• MDR Report Key: 16283267
• MDR Text Key: 308649275
• Report Number: 16283267
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 85900P
• Device Lot Number: 0302702133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/26/2023
• Event Location: Other
• Date Report to Manufacturer: 02/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31390 DA