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

Model Number S5IX

Device Problems Incorrect Measurement (1383); Inaccurate Synchronization (1609)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This case was reviewed and investigated according to philips volcano policy.Attempt to obtain patient information have been unsuccessful.Attempt to obtain the patient information were made via email and phone.All reasonably known patient information is included in this report.The system was analysed and repaired at the facility; it was not returned to the manufacturer.The cause of the pd pa waveform time shift issue is under investigation in accordance with philips volcano policy.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.To date, no other complaints were reported for this same failure mode for the same system/asset.This complaint will be monitored as part of complaint data analysis.

Event Description

The manufacturer's sales manager reported a delay between pa (pressure proximal to the lesion) and pd (pressure distal to the lesion).There was no patient injury.The manufacturer's field service engineer (fse) visited the site and confirmed the delay with the pa/pd pressure screening.The engineer exchanged the core cpu, retrieved the data back to the new cpu, performed an annual preventive maintenance (pm) check and stk ("sicherheitstechnische kontrolle), an electrical safety test.The engineer indicated the system works to designed specifications.

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: 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: 5851226
• MDR Text Key: 51295157
• Report Number: 2939520-2016-00053
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082229
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 06/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S5IX
• Device Catalogue Number: 807400001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2009
• 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: 104