MAUDE Adverse Event Report: VOLCANO CORPORATION VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number CORE MOBILE

Device Problem Inaccurate Synchronization (1609)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This case was reviewed and investigated according to the manufacturer's policy.Relevant test lab data: no tests/laboratory data was available.Other relevant history: no information was available.The udi number is not applicable to this device as it was manufactured prior to 09-24-2016.There is not lot number or expiration date tied to this device.Implant date: this device is not applicable to this section.Explant date: this device is not applicable to this section.The system was analyzed and repaired at the facility; it was not returned to the manufacturer.Initial reporter: country code is (b)(6) and system is incorrectly populating the country as (b)(6).The cause of the pa/pd waveform time shift issue has been investigated by the manufacturer.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.

Event Description

The hospital reported to the manufacturer that there was a delay between the ao and distal pressure.Due to the delay, the hospital stated that it was not possible to normalize ao and distal pressures.No patient injury or harm.

Manufacturer Narrative

Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer's policy.Based on the previous assessment of this pa-pd shift complaint, the initial information available suggested that if pa-pd waveform shift occurs, inaccurate measurements could contribute to incorrect treatment decisions.The manufacturer's operator's manual requires use only by trained medical personnel and cautions that "federal law restricts this device to sale by or on the order of a physician (or properly licensed practitioner)." additionally, the operator's manual states that the ffr option on the manufacturer's system should be used only by physicians who are thoroughly trained in cardiac or peripheral vessel catheterization procedures.The fractional flow reserve (ffr) option on the manufacturer's system requires two pressure signals (pd and pa) to execute normalization and calculate results.The manufacturer's pressure wire, provides the distal pressure signal (pd).The physiologic aortic pressure signal (pa) comes from a sensor that is part of the hemodynamic monitoring system, a non-manufacturer's product.The aortic pressure sensor and attached guide catheter are set-up and positioned by the physician separate from manufacturer's pressure wire.Normalization is performed with the wire's pressure sensor located at the tip of the guide catheter within the coronary artery.Therefore, the physician initiates normalization once they have confirmed the placement of the pressure wire.Based on the above described factors (pd coming from volcano's pressure wire, pa coming from a non-manufacturer's product, and physician's initiation of normalization upon confirmation of placement of pressure wire), the physiologic aortic pressure signal can contain content that may cause a one cardiac cycle shift.Refer to manufacturer's operator's manual, section acquire ffr pressure measurements for warning on discontinuing use of the system, and contacting manufacturer's technical support if normalization fails to establish a pd/pa ratio of 1.0 after multiple attempts.Manufacturer's product manages such a shift by displaying the normalized waveforms so that the user can detect a one-cardiac cycle shift.Manufacturer's software (ffr v2.4 software) allows the user to evaluate the results of the normalization process and make adjustments if needed.The one-cardiac cycle shift is not caused by manufacturer's software and this not a product performance issue, as the product is working as designed the appropriate action is to review the presented waveforms and re-normalize with the goal of achieving a shift free normalization.Manufacturer's ffr v2.4 operator's manual has instructions in that if the user is unable to establish a post-normalization pd/pa ratio of 1.0 with overlapping waveforms after several attempts, they are instructed to contact manufacturer's technical support.As described in this document, ffr version v2.4 is performing as intended.

Event Description

This event is being submitted to correct and clarify information provided in the initial report.

• Brand Name: VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore road; rancho cordova CA 95670
• 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: 6183384
• MDR Text Key: 62703719
• Report Number: 2939520-2016-00086
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CORE MOBILE
• Device Catalogue Number: 400-0100.07
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2016
• 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: 77 YR
• Patient Weight: 65