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	02/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a core m2 system was used in a procedure.During use, the system failed to recognize the ivus pim and an error message was displayed on the monitor.The procedure was aborted and will be rescheduled at 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.
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Block a2-a6: date of birth, age at time of event, sex, gender, weight, ethnicity, and race not available from the facility.Blocks b6 & b7: not available from the facility.Block c: not applicable.Block d4: expiration date is not applicable.Blocks d6 & d7: not applicable for this device.Blocks h3 & h6: a new ivus pim cable was sent to the facility; customer replaced the part and resolved the issue.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 h6: the initial mdr stated that a new ivus pim cable resolved the issue.However, new information indicated that two components (ivus pim and ivus pim cable) were replaced, but has not fully resolved the issue since the system only works intermittently.Based on this new information, the cause could not be established.Investigation conclusions code updated to d15 (caused not established) from d02 (cause traced to component failure).

• 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: diana melliza galvez ; 3721 valley centre drive #500; san diego, CA 92130 ; 510933-4541
• MDR Report Key: 21576497
• Report Number: 3008363989-2025-00031
• Device Sequence Number: 20940194
• Product Code: IYO
• UDI-Device Identifier: 00845225012663
• UDI-Public: (01)00845225012663(11)191021(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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

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: 02/10/2025
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2019
• 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: UNK MFG AND SIZE: GUIDE CATHETER.; UNK MFG AND SIZE: GUIDE WIRE.; UNK MFG AND SIZE: INTRODUCER SHEATH.
• Patient Sex: Prefer Not To Disclose