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

Model Number CORE MOBILE IMAGING SYSTEM

Device Problem Inaccurate Synchronization (1609)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The udi number is not applicable to this device as it was manufactured prior to 09-24-2016.

Event Description

This case was reviewed and investigated according to the manufacturer's policy.The customer reported a delay between ao and distal pressure.Due to the delay, it was not possible to normalize ao and distal pressures.There was no patient injury or adverse event.The system was analyzed at the facility.A vh board was replaced but the problem was not fully resolved.The unit is scheduled to be replaced.Upon its return, the unit is scheduled for investigation and refurbishment.We are reporting this case as delays between pa(ao) and pd signals has the potential to lead to misdiagnosis.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.

Manufacturer Narrative

Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer's policy.Device was returned on 04-04-2017.The returned core mobile system was visually inspected and no damage was noticed.The returned device was investigated according to the manufacturer's policy.An investigation of the returned device confirmed this to be the case in that the shift was observed.During the functional test, after "normalization" was pressed, the system exhibited a one cardiac cycle shift.The physiologic aortic pressure signal can contain content that can cause a one cardiac cycle shift.The investigation concluded that the system operated as intended.Additionally, instructions are provided to the user and contained within the operator's manual: - warning: normalize adjusts the distal pressure (pd) measurement from the pressure wire to match the aortic pressure (pa) reading.It also adjusts the time delay between the pd and pa signals to synchronize their display, a shift that is usually apparent only during the first normalization in a new system setting.If pd and pa waveforms do not overlap, repeat normalization step.- verify that pd (distal pressure) is equal to pa (aortic pressure) and the pd/pa ratio is 1.0.If pd/pa a ratio is not 1.0, repeat normalization step.- warning: if normalization fails to establish a pd/pa ratio of 1.0 after multiple attempts, discontinue system use and contact technical support immediately.

Manufacturer Narrative

Internal reference: (b)(4).(date received by manufacturer): supplemental report #1; device was returned on 04-04-2017 and inadvertently noted as the aware date.A technical assessment was completed on 05-01-2017 which determined that the software did not malfunction.(date received by manufacturer): supplemental report #2; the aware date for this submission is 05-01-2017.

Event Description

This event is being reported to correct the (aware date) submited on 05-04-2017 for mdr 2939520-2017-00001 supp 1.

• Brand Name: CORE MOBILE
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): VOLCANO CORPORATION; 3721 valley centre dr ste 500; san diego CA 92130
• Manufacturer (Section G): VOLCANO CORPORATION; 2870 kilgore road; rancho cordova CA 95670
• Manufacturer Contact: tom brennan ; 3721 valley centre dr #500; san diego, CA 92130 ; 8587641320
• MDR Report Key: 6248355
• MDR Text Key: 64735336
• Report Number: 2939520-2017-00001
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K153369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CORE MOBILE IMAGING SYSTEM
• Device Catalogue Number: 400-0100.07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2016
• 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 Age: 51 YR
• Patient Weight: 64