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

Model Number	797403
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an intrasight system was used in a coronary procedure.During use, the pd value was inaccurate, value was drifting, and unable to normalize.The ifr procedure was aborted and the patient will be treated in a different lab, scheduled two days later.No patient injury reported.This product problem is being reported because the procedure was aborted, 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 d4, d6 & d7: not applicable for this system.Blocks h3 & h6: a field service engineer visited the site on 19dec2025.The fm-pim and pim extension cable were replaced and system checkout was completed.The system met specifications and 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.
Additional Manufacturer Narrative
Blocks d9 & h3: the fm-pim was returned for evaluation.Block h3: visual inspection of the fm-pim (ivus pim) found no damage observed.During functional testing, the ivus pim was connected to an intrasight lab system and was able to be recognized as expected, even upon manipulation of the connection, and disconnecting/reconnecting to the system.Block h6: based on the device evaluation, the reported complaint could not be replicated.The ivus pim performed as intended; therefore, the probable cause 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.

• 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: ana tan ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4037
• MDR Report Key: 24030930
• Report Number: 3008363989-2026-00007
• Device Sequence Number: 15695674
• Product Code: IYO
• UDI-Device Identifier: 00845225012878
• UDI-Public: (01)00845225012878(11)210604(10)1404876
• 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,Followup
• Report Date (Section B): 03/06/2026

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: 1404876
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2020
• 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 WIRE, TYPE UNK
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White