MAUDE Adverse Event Report: PHILIPS IMAGE GUIDED THERAPY CORPORATION VISIONS PV .018 DIGITAL IVUS CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	86700
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
When the ivus [intravascular ultrasound] was loaded onto the wire and placed into the patient vessel, it was then plugged into the power source.The catheter would not work.

• Brand Name: VISIONS PV .018 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: 22296829
• Report Number: 22296829
• Device Sequence Number: 20946907
• Product Code: OBJ
• UDI-Device Identifier: 00184360000037
• UDI-Public: (01)00184360000037(11)240916(17)260916(10)0303288950
• 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): 06/13/2025
• Report Date (Section F): 06/13/2025

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: 86700
• Device Catalogue Number: 86700
• Device Lot Number: 0303288950
• 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: 06/20/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/20/2025
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Date Report Sent to FDA: 06/13/2025