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

Model Number	400-0100.02
Medical Device Problem Code	Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacture¿s policy.Blocks h3 & h6: at the customer site, a field service engineer replaced the core system power supply.The system met the specification for the performed service and now available for use.Blocks h7 & h9: 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 the core system lost power halfway through an emergent coronary procedure.The attempt to regain power lasted about 45 mins to an hour.The patient was transferred to another cath lab with an operating ivus.There was no report of patient harm.This adverse event and product problem is being submitted due to the system power outage, resulting in a delay of procedure.
Additional Manufacturer Narrative
Block d: brand name was updated from "core" to "core integrated imaging system" to match the product label.Catalog # was updated from "300004330631" to "400-0100.02".Model number was updated from "core01" to "400-0100.02".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 INTEGRATED IMAGING 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 ; 619633-4179
• MDR Report Key: 17374954
• Report Number: 3008363989-2023-00033
• Device Sequence Number: 17901383
• Product Code: IYO
• UDI-Device Identifier: 00845225010300
• UDI-Public: (01)00845225010300(11)180525(90)989609000071
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K153369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White