MAUDE Adverse Event Report: VOLCANO CORPORATION CORE SERIES PRECISION GUIDED THERAPY SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	400-0100.02
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
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.Block h3 & h6: at the customer site, a field service engineer replaced the touchscreen control pad and interface cable.The system met specification and 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.
Event or Problem Description
It was reported that a core system was used in a procedure.During use, there was no display since the touch panel was not working.After unplugging/plugging in the cable to the control pad, the system did power on but it was too late into the exam to use the system.The procedure could not be completed and had to be rescheduled.No patient injury was 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
Block d9: the core system component was returned for evaluation.Block h3: visual inspection of the core control pad found no damage observed.During functional testing, the control pad was connected to a good known bub and core system.Touch was responsive and accurate across the entire screen, which remained visible for the entirety of the testing.Navigation using the control pad was functional, as well.Additionally, the power was disconnected and reconnected multiple times, and each time the results were the same.Block h6: the probable cause of the reported failure (no display) 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 SERIES PRECISION GUIDED THERAPY 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: 21753153
• Report Number: 3008363989-2025-00043
• Device Sequence Number: 15865039
• Product Code: IYO
• UDI-Device Identifier: 00845225010300
• UDI-Public: (01)00845225010300(11)170515
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113486
• 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,Followup
• Report Date (Section B): 07/09/2025

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: 400-0100.02
• Device Catalogue Number: 400-0100.02
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: GUIDEWIRE; UNK MFG AND SIZE: INTRODUCER SHEATH
• Patient Sex: Unknown