MAUDE Adverse Event Report: VOLCANO CORPORATION CORE MOBILE SYSTEM MEDICAL EQUIPMENT; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	400-0100.07
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a core mobile system was used in a procedure.During use, pressure measurements were not possible.The system was unplugged and rebooted, but could not be resolved.A break was observed on the ffr pimmette cable; therefore, the cable was replaced but did not fully resolve the issue.It is unknown how the procedure was completed and if the device was being used in an emergent procedure.No patient injury reported.This product problem is being reported in an abundance of caution because it is unknown if the failure occurred during an emergent procedure; potential for harm.
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacture¿s policy.Blocks a2-a6: not available from facility.Blocks b6 & b7: not available from facility.Block c: not applicable.Block d4: expiration date is not applicable.Blocks d6 & d7: not applicable.Blocks e1 & g2: country is germany.Block h3 & h6: at the customer site, a field service engineer replaced the ffr pimmette cable and hemo cable.System meets the specification for the performed service and is 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 core mobile system component was returned for evaluation.Block h3: visual inspection of the ffr pimmette found no break or damage to the device.During functional testing, the ffr pimmette was connected and recognized by the system.The device functioned as expected with a pressure wire simulator, even upon manipulation of the cable connection, and disconnecting/reconnecting the ffr pimmette.Block h6: the probable cause of the pressure measurement issue could not be determined since the device performed as intended.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: CORE MOBILE SYSTEM MEDICAL EQUIPMENT
• 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: 22795071
• Report Number: 3008363989-2025-00101
• Device Sequence Number: 20993357
• Product Code: IYO
• UDI-Device Identifier: 00845225012274
• UDI-Public: (01)00845225012274(11)170208
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K123898
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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: 400-0100.07
• Device Catalogue Number: 400-0100.07
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2017
• 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
• Patient Sex: Unknown