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

Model Number CORE INTEGRATED

Device Problems Environmental Compatibility Problem (2929); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 11/23/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).This case was reviewed and investigated according to the manufacturer's policy.Attempts to obtain patient information have been unsuccessful.Attempts to obtain the patient information were made via email and phone.Attempts to date to obtain date of death were unsuccessful.The hospital did not inform the manufacturer of this event.The manufacturer's sales manager for the hospital was apprised of the event on (b)(6) 2017, who contacted the hospital same day.The nurse at the hospital explained the incident occurred during an ivus procedure and that the monitor shut down (no image) and therefore, there was a prolongation of the case.The nurse said it was a complex situation due to the patient's condition and the patient's death was probably not caused by our devices.The nurse had no more information but indicated she would try to obtain additional information from the physician regarding the procedure.As of the date of this report submission, no further information regarding the procedure is known by the manufacturer.Per the customer's biomedical department on (b)(6) 2017, no problems were logged in their system.A lot number is not applicable to this device.The udi number is not applicable to this device as it was manufactured prior to 09-24-2016.The implant or explant dates are not applicable to this device based on current information.System was investigated in the field at the customer's site.System was not returned to the manufacturer.(b)(6).A field service engineer (fse) from the manufacturer was sent to the customer to inspect the system on (b)(6) 2017.The fse did not notice any problems with the system and performed a preventive maintenance(pm) and completed the pm checklist.The cmos battery was replaced as part of the pm.An electrical safety check was performed.The fse noted the system is operating as intended.A review of complaint cases submitted for this asset was performed and no other similar complaints were reported on this asset for this failure.This complaint will be monitored as part of complaint data analysis.

Event Description

On (b)(6) 2017 the manufacturer received an e-mail from (b)(6) health care inspectorate informing us the manufacturer's customer reported to the inspectorate that a patient had died during a percutaneous coronary intervention (pci) procedure.It was also reported within the email that one of the causes could be a delay of the procedure; the delay could have been caused by a malfunction of the system.This event is being reported as an adverse event of patient death occurred in which the system from the manufacturer may have been used during the referenced procedure.

Manufacturer Narrative

Internal reference: (b)(4).The facility initially indicated the that the monitor shut down (no image) as previously reported.On (b)(6) 2017 the facility said the monitor went into sleeping mode.The manufacturer was able to clarify with the facility on (b)(6) 2017 that when they indicated the monitor went into sleeping mode, they meant the system froze.A review of the monitor images was performed by the manufacturer.The captured monitors do not have a sleep function.Complaint cases were reviewed for complaints related to this event between the time periods of january 2015 through june 2017.There were no previous complaints similar to this event, i.E.: where both monitors turned black and the system froze.The probable cause of the failure was likely due to a loss of power to the system and not a failure of the system itself as the reported failure could not be duplicated by the field service engineer (fse).The operator's manual for the system, page 52, under "ensure system power is on" instructs: the system power for the manufacturer's system should be turned on at the beginning of each day and turned off at the end.Turn the system on by using the power button located on the front of the workstation.The monitor displays several messages regarding initialization.If an error occurs during initialization, an information box provides detailed information about the problem to expedite service.Please contact the manufacturer's technical support if an error is encountered.Equipotentiality: this symbol on the system rear electrical panel identifies the connector where the hospital room's potential equalization system can be connected during intracardiac applications.This connector on the isolation transformer is connected by an 8awg green and yellow striped wire to the bus bar in the x-ray equipment cabinets that serves the potential equalization ground for the patient table in the exam room.(equipotentiality cords are available from the manufacturer's service: singled ended, and double ended.Power cord: can be detached from the system by loosening the screw on the cord retainer and unplugging the cord from the system.Note: leave the power on during the case unless there is an emergency.

Event Description

This supplemental follow-up report is being submitted because additional information was obtained.

• Brand Name: CORE
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): VOLCANO CORPORATION; 1 fortune dr; bellerica MA 01821
• Manufacturer (Section G): VOLCANO CORPORATION; 2870 kilgore road; rancho cordova CA 95670
• Manufacturer Contact: tom brennan ; 3721 valley centre dr ste 500; san diego, CA 92130 ; 8587641320
• MDR Report Key: 6683270
• MDR Text Key: 78895241
• Report Number: 2939520-2017-00061
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K133641
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CORE INTEGRATED
• Device Catalogue Number: 400-0100.02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death