MAUDE Adverse Event Report: VOLCANO CORPORATION CORE M2 VASCULAR SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	400-0100.17
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.At the customer site, the field service engineer replaced the hard drives and reloaded the 4.2 software.The system information was verified and the issue was resolved.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 a core m2 system was used in an procedure.During use, an error message was displayed on the monitor.The system was rebooted three times without success.The case was aborted and rescheduled for a later date.No patient injury reported.This product problem is being reported because the core m2 system could not be used; resulting in a potential for harm due to the delay of the procedure.

• Brand Name: CORE M2 VASCULAR 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: danielle bullock ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4125
• MDR Report Key: 21096974
• Report Number: 3008363989-2025-00004
• Device Sequence Number: 18376374
• Product Code: IYO
• UDI-Device Identifier: 00845225012663
• UDI-Public: (01)00845225012663(11)200805(90)989609000151
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170385
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/07/2025

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: 400-0100.17
• Device Catalogue Number: 400-0100.17
• 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: 12/12/2024
• Initial Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2020
• 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: 5F GUIDE CATHETER, MFG UNK; CORDIS: BRITE TIP INTRODUCER SHEATH, SIZE UNK; TERUMO: ADVANTAGE GUIDEWIRE, SIZE UNK
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White