MAUDE Adverse Event Report: PHILIPS IMAGE GUIDED THERAPY CORPORATION VERISIGHT PRO INTRACARDIAC ECHOCARIOGRAPHY CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	VSICE3D
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During prep, the versight ice catheter displayed an error message.The catheter was removed and replaced and, with no harm to the patient.Manufacturer response for catheter, verisight pro ice catheter, intracardiac and intra-luminal visualization (per site reporter).Mfg [manufacturer] notified by site.

• Brand Name: VERISIGHT PRO INTRACARDIAC ECHOCARIOGRAPHY CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS IMAGE GUIDED THERAPY CORPORATION; 2451 mercantile drive; rancho cordova CA 95742
• MDR Report Key: 22622807
• Report Number: 22622807
• Device Sequence Number: 8429215
• Product Code: OBJ
• UDI-Device Identifier: 00845225003036
• UDI-Public: (01)00845225003036
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 07/10/2025
• Report Date (Section F): 07/10/2025

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
• Device Model Number: VSICE3D
• Device Catalogue Number: VSICE3D
• Device Lot Number: 303358281
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2025
• 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 Sex: Unknown
• Date Report Sent to FDA: 07/10/2025