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

Model Number	797415
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an intrasight mobile system was to be used for a stent placement procedure.However, during use, the system was unable to recognize the ivus-pim and displayed a "connect pim" error, even when connected.The procedure was stopped since ivus was needed for proper stent sizing, and rescheduled for a later date.No patient injury reported.This product problem is being reported because the system could not be used; 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 & a3b-a6: not available from facility.Blocks b6 & b7: not available from facility.Block c: not applicable for this system.Blocks d4, d6 & d7: not applicable for this system.Blocks h3 & h6: philips field service engineer determined the pim cable required replacement.A pim cable was sent to the facility for replacement, the old pim cable was discarded; no further issues have been reported.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.

• 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: 24956701
• Report Number: 3008363989-2026-00065
• Device Sequence Number: 10315665
• Product Code: IYO
• UDI-Device Identifier: 00845225012915
• UDI-Public: (01)00845225012915(11)210325(10)0302217628
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2026

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: 0302217628
• 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: 04/08/2026
• Initial Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2021
• 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