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	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacture¿s policy.Blocks a2-a6: no patient involvement.Blocks b6 & b7: no patient involvement.Block c: not applicable.Block d4: expiration date is not applicable.Blocks d6 & d7: not applicable.Blocks e1 & g2: country is spain.Block h3: at the customer site, a field service engineer replaced the bub.The system was returned for use.During the device evaluation, thermal damage was confirmed on the bub (+24v connector).Block h6: the probable cause of the thermal damage to the +24v connector is likely due to an internal component failure.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 during preventative maintenance for the core system, the pressure guide was not working properly.A field service engineer was on site and replaced the bub, and the system was returned for use.There was no patient involvement and no user injury reported.During the device evaluation, thermal damage was observed on the bub (+24v connector).This product problem is being reported due to the confirmed thermal damage, resulting in a potential for harm.

• 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: ayse kharodawala ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4063
• MDR Report Key: 21261055
• Report Number: 3008363989-2025-00012
• Device Sequence Number: 9412929
• Product Code: IYO
• UDI-Device Identifier: 00845225010300
• UDI-Public: (01)00845225010300(11)190320(90)989609000071
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/28/2025

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
• Date Returned to Manufacturer: 01/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2019
• 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