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	11/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The ivus was displaying a weird picture the first time being used in this case.The doctor decided to swap it out for another 0.018 ivus.When the ivus was taken out of the patient the tip dislodged completely from the rest of the catheter.

• Brand Name: VISIONS PV .018 DIGITAL IVUS CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS IMAGE GUIDED THERAPY CORPORATION; 3721 valley centre dr; suite 500; san diego CA 92130
• MDR Report Key: 23815579
• Report Number: 23815579
• Device Sequence Number: 21325623
• Product Code: OBJ
• UDI-Device Identifier: 00184360000037
• UDI-Public: (01)00184360000037(11)250610(17)270610(10)0303488780
• 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): 11/24/2025
• Report Date (Section F): 11/24/2025

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: 0303488780
• 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: 12/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2025
• 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: 18 YR
• Patient Sex: Female
• Patient Weight: 111 KG
• Date Report Sent to FDA: 11/24/2025