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	02/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Block h3: the system components (hemo cable and fm-pim cable) were discarded by the facility, thus no returned product investigation was performed.Block h6: the facility received parts (hemo cable and fm-pim cable) to perform the replacement; hence, no onsite service was needed.No customer complaints have been received after the replacement parts were sent to facility.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 a coronary procedure.During use, the yellow wave form (pd) would not appear on the system.The case was aborted and the patient will be rescheduled for a later date.No patient injury reported.This product problem is being reported because the intrasight system could not be used; 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: 24597959
• Report Number: 3008363989-2026-00047
• Device Sequence Number: 9561487
• Product Code: IYO
• UDI-Device Identifier: 00845225012878
• UDI-Public: (01)00845225012878(11)230118(10)1428424018
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2026

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: 1428424018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: OMNIWIRE; UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: INTRODUCER SHEATH
• Patient Sex: Unknown