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

Model Number 807400001

Device Problem Inaccurate Synchronization (1609)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts to obtain patient information concerning gender, age and weight have been unsuccessful.Attempts to obtain the patient information were made via email and phone.All reasonably known patient information is included in this report.No tests/laboratory data was available.Lot number: this "blank" is not an omission.There is no expiration date associated with this product.Expiration date: this "blank" is not an omission.There is no lot associated with this product; it is referenced by serial number.The system was manufactured prior to 09-24-2016.The implant or explant dates are not applicable to this device.The system was analyzed and repaired at the facility by the manufacturer's field service engineer.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 the alleged death or deterioration in the state of the health of any person.

Event Description

This case was reviewed and investigated according to the manufacturer's policy.It was reported the system displayed a pa / pd delay and low ifr value after normalizing during an ifr case and noted the pd waveform did not match the pa waveform.Three unsuccessful attempts were made with three different wires before the procedure was aborted.There were no adverse events and no patient injury.A field service engineer (fse) visited the site and was unable to confirm the reported failure.The system tested fully operational with no issues using approved simulators.As the site had an image displaying the waveform delay, the fse went ahead and repaired the system by replacing the hard drives and 3.4 software, and activated ifr.The system was rechecked and retested.It operated as intended.There were no outstanding action items.No components were returned for analysis.The old hard drives were turned over the cath lab staff.This event is being reported because a delay between pa (ao) and pd signals has the potential for inaccurate readings.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

(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: S5/S5I SERIES INTRAVASCULAR 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: 6378740
• MDR Text Key: 69106912
• Report Number: 2939520-2017-00027
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082229
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 807400001
• Device Catalogue Number: 807400001
• 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: 06/04/2011
• 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