MAUDE Adverse Event Report: VOLCANO CORPORATION S5IX 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 01/18/2017

Event Type  malfunction  

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.All reasonably known patient information is included in this report.Relevant test lab data: no tests/laboratory data was available.Relevant history: no information was available.This "blank" is not an omission.There is no expiration date associated with this product.This "blank" is not an omission.There is no lot associated with this product; it is referenced by serial number this "blank" is not an omission.The udi number is not applicable to this device as it was manufactured prior to 09-24-2016.Implant and explant dates: this "blank" is not an omission.The implant or explant dates are not applicable to this device.

Event Description

This case was reviewed and investigated according to the manufacturer's policy.The customer reported a delay between ao and distal pressure and low ifr value after normalizing.The physician used another system to successfully complete the case with no reported patient injury or adverse event.The system was analyzed by a field service engineer (fse) at the customer's facility.The fse was unable to duplicate the reported event however a review of an image provided by the facility indicated a waveform delay.The fse replaced the hard drive, loaded software, calibrated and tested the system.The system was deemed operational with no further action required.We are reporting this case as delays 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: S5IX 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: 6341544
• MDR Text Key: 67926786
• Report Number: 2939520-2017-00020
• 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: Health Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• 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?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2010
• 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