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

Model Number 10185J

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2015

Event Type  malfunction  

Manufacturer Narrative

Internal reference: (b)(4).This case was reviewed and investigated according to volcano policy.It was observed during the visual inspection at decontamination the sensor was intact, tip coil was broken and the solder dome was missing.Further investigation of the device confirmed the distal coil was stretched and part of the distal coil and the dome were not present.No mention was provided in the complaint of a piece of the wire being broken or missing.We are unable to determine when or how the separation occurred.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 within this lot.We will continue to monitor these types of complaints.

Event Description

A signal/connection issue was reported as "no pd pressure." no patient injury.All reasonably known patient information is included in this report.

• 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): VOLCANO CORPORATION; 2870 kilgore road; rancho cordova CA 95670
• Manufacturer Contact: richard welch ; 3721 valley centre dr #500; san diego, CA 92130 ; 8587641301
• MDR Report Key: 5125556
• MDR Text Key: 27419989
• Report Number: 2939520-2015-00050
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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
• Report Date: 09/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/31/2017
• Device Model Number: 10185J
• Device Catalogue Number: 10185J
• Device Lot Number: 0244 20038958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2014
• 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