MAUDE Adverse Event Report: VOLCANO CORPORATION VERRATA PRESSURE GUIDE WIRE; WIRE, GUIDE, CATHETER

Model Number 10185

Device Problem Device Abrasion From Instrument Or Another Object (1387)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2016

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.No tests/laboratory data was available.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.There were no nonconforming material reports or deviations noted that would contribute to the reported failure mode.This complaint will be monitored as part of complaint data analysis.

Event Description

This case was investigated in accordance with philips volcano policy.It was reported during a diagnostic procedure, the error message "attach wire to connector" was displayed.Per the source document, the wire was not recognized by the system and was not zeroed.There were no adverse events and no patient impact.Another wire of same product was opened and the procedure was completed.A visual inspection was performed on the returned device.The hypotube was broken and the trifilar was severed at 644 mm from the proximal end of the wire.The core wire was exposed due to the damage, but the wire was still intact.Scuffing of ptfe coating was also observed at 624 mm, 680 mm and 749 mm from the proximal end of the wire.Multiple kinks and bends were observed along the hypotube.The distal tip was curved.The dome was corroded.There was some residue on the sensor.The device was still intact.We are reporting this event in an abundance of caution.If the event were to recur there is a potential for harm if the wire was introduced into the patient.

• Brand Name: VERRATA PRESSURE GUIDE WIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore road; rancho cordova CA 95670
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone&business park; b37; alajuela, costa rica ; CS
• Manufacturer Contact: tom brennan ; 3721 valley centre dr #500; san diego, CA 92130 ; 8587641320
• MDR Report Key: 6168540
• MDR Text Key: 62386024
• Report Number: 2939520-2016-00085
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131288
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2019
• Device Model Number: 10185
• Device Catalogue Number: 400-0300.16
• Device Lot Number: 0243 50073298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1