MAUDE Adverse Event Report: VOLCANO CORPORATION INTRASIGHT MOBILE SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	797415
Medical Device Problem Code	Computer Operating System Problem (2898)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Blocks a2-a6: not available from facility.Blocks b6 & b7: not available from facility.Block c: not applicable for this system.Blocks d6 & d7: not applicable for this system.Blocks h3 & h6: at the customer site, a field service engineer replaced the ace card.System meets the specification for the performed service and is returned to use.Blocks h7, h9 & h10: do not apply to this submission.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
Event or Problem Description
It was reported that an intrasight mobile system was used in a procedure.During use, the system encountered a modality error.The procedure was aborted and rescheduled for a later date.No patient injury reported.This product problem is being reported because the procedure has to be rescheduled; resulting in a potential for harm due to the delay of the procedure.

• Brand Name: INTRASIGHT MOBILE SYSTEM
• Common Device Name: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): VOLCANO CORPORATION; 3721 valley centre drive #500; san diego CA 92130
• Manufacturer (Section G): VOLCANO CORPORATION; 3721 valley centre drive #500; san diego CA 92130
• Manufacturer Contact: diana melliza galvez ; 3721 valley centre drive #500; san diego, CA 92130 ; 510933-4541
• MDR Report Key: 24273817
• Report Number: 3008363989-2026-00015
• Device Sequence Number: 10723300
• Product Code: IYO
• UDI-Device Identifier: 00845225012915
• UDI-Public: (01)00845225012915(11)250130(10)1458014030
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K203719
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2026

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: 797415
• Device Catalogue Number: 797415
• Device Lot Number: 1458014030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER, MFG AND SIZE UNK; GUIDE WIRE, MFG AND SIZE UNK; INTRODUCER SHEATH, MFG AND SIZE UNK; PHILIPS: IVUS CATHETER, MODEL UNK
• Patient Sex: Unknown