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

Model Number	797403
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Block a2-a6: no information available.Blocks b6 & b7: no information available.Block c: not applicable for this device.Blocks d4, d6 & d7: not applicable for this system.Block h3: at the facility, the fse replaced the ace card, tested, and returned for use.The ace card was returned for evaluation.Visual inspection found no damage observed.During functional testing, the component was connected to a lab system and recognized.When attempting to test in ivus mode, a hardware fault error citing code "ivacepi0016" appeared.Block h6: the probable cause of the reported error message is likely due to the electrical component failure since the intrasight system worked after the ace card was replaced.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 system was used in an emergent procedure.During use, an error message was displayed on the monitor, even after multiple attempts to reboot the system.The procedure was completed without the ivus system.No patient injury reported.This product problem is being reported because the system could not be used during an emergent case; resulting in a potential for harm due to the delay of the procedure.

• Brand Name: INTRASIGHT
• 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: danielle bullock ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4125
• MDR Report Key: 24171200
• Report Number: 3008363989-2026-00010
• Device Sequence Number: 21369806
• Product Code: IYO
• UDI-Device Identifier: 00845225012878
• UDI-Public: (01)00845225012878(11)250513(10)1460324133
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2026

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: 797403
• Device Catalogue Number: 797403
• Device Lot Number: 1460324133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2025
• 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: PHILIPS IVUS DEVICE, MODEL UNK.; UNK MFG AND SIZE: GUIDE CATHETER.; UNK MFG AND SIZE: GUIDEWIRE.; UNK MFG AND SIZE: INTRODUCER SHEATH.
• Patient Sex: Unknown