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

Model Number	85900P
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient brought to cardiac catheterization lab (ccl), cleaned and prepped in surgical manner.Guidewire and intravenous ultrasound (ivus) catheter inserted into patient.However, the guidewire got stuck in ivus catheter and can't be removed.Both guidewire and ivus catheter were withdrawn.Both devices were exchanged for similar ones and the procedure was done without any further incident.Patient tolerated procedure well and was brought to recovery room in stable condition.Manufacturer response for catheter, ultrasound, intravascular, eagle eye platinum (per site reporter).Catheterization lab manager informed field representative after the case and on that same day, field representative came and got the device.

• Brand Name: EAGLE EYE PLATINUM
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS IMAGE GUIDED THERAPY CORPORATION; 5905 nathan lane north; plymouth MN 55442
• MDR Report Key: 19320423
• Report Number: 19320423
• Device Sequence Number: 15351446
• Product Code: OBJ
• UDI-Device Identifier: 00845225001278
• UDI-Public: (01)00845225001278(11)231020(17)251020(10)0303026714
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/22/2024
• Report Date (Section F): 01/22/2024

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: 85900P
• Device Catalogue Number: 85900P
• Device Lot Number: 0303026714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2024
• 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: 54 YR
• Patient Sex: Male
• Patient Weight: 116 KG
• Patient Ethnicity: Hispanic
• Patient Race: White
• Date Report Sent to FDA: 01/22/2024