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

Model Number	797403
Medical Device Problem Code	Computer Operating System Problem (2898)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an intrasight system was used in an emergent stemi procedure.During use, the system had an error message (ivus is not available); therefore, it could not be used.The procedure was completed with a mobile 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.
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Blocks a2-a6: no information available.Blocks b6 & b7: no information available.Block c: not applicable for this system.Block d4: expiration date is not applicable for this system.Blocks d6 & d7: not applicable for this system.Blocks h3 & h6: at the customer site, the field service engineer found motherboard logic failure and no video signal to the monitor.The defective workstation and bub (bedside utility box) were replaced.The system was tested, verified, and returned for 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.
Additional Manufacturer Narrative
Block h3: the bub (bedside utility box) was returned for evaluation without the ivus v3 connector installed in the device.Visual inspection found no unusual characteristics of the device.During functional testing, the bub was connected to the intrasight console, the led on the fm-pim lit up in blue, indicating that the device was recognized successfully.However, further testing of the ivus mode could not be performed due to the missing ivus v3 connector.Block h6: based on the available testing, no problem was detected.However, due to the incomplete testing, the probable cause of the reported failure "ivus not available error" could not be established.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.
Additional Manufacturer Narrative
Block h3: the intrasight workstation was returned for evaluation.Visual inspection found no unusual characteristics of the device.During functional testing, the workstation was connected to the lab system, and immediately turned on without pressing the main power button; however, no video signal was present on the display monitor, even after multiple power up attempts, and disconnecting/reconnecting video output cables.Block h6: based on the available testing, the probable cause of the reported failure "ivus not available error" could not be conclusively determined since the device displayed no video signal to continue testing.However, the probable cause of the no video signal is likely due to an internal component failure.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.

• 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: ayse kharodawala ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4063
• MDR Report Key: 24308135
• Report Number: 3008363989-2026-00018
• Device Sequence Number: 21247947
• Product Code: IYO
• UDI-Device Identifier: 00845225012878
• UDI-Public: (01)00845225012878(11)220815(10)1422443227
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2026

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: 1422443227
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 03/25/2026; 04/10/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 04/06/2026; 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2022
• 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 DEVICE: TYPE UNKNOWN
• Patient Sex: Unknown