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

Model Number 10185

Device Problem Insufficient Information (3190)

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

Event Date 11/26/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The implant or explant dates are not applicable to this device.Per the instructions for use (ifu) warns, never advance, torque or retract a pressure guide wire which meets significant resistance.The ifu also cautions, the pressure guide wire should not be advanced if resistance is encountered.The wire should never be forcibly pushed into a vessel.Any time that resistance is encountered, the wire should be withdrawn under fluoroscopic guidance.In some instances, the wire may kink and must be removed.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.

Event Description

This case was reviewed and investigated according to the manufacturer's policy.It was reported, during a diagnostic coronary procedure when inserting the manufacturer's device, it kinked with another manufacturer's catheter.The manufacturer's device was removed at the same time as another device.This event is being reported because the manufactures device and another manufacturer's guide catheter were removed as a system.

• 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, ; CS
• Manufacturer Contact: melissa pieplow ; 2870 kilgore road; rancho cordova, CA 95670 ; 9163651925
• MDR Report Key: 8177139
• MDR Text Key: 130971138
• Report Number: 2939520-2018-00207
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 845225002435
• UDI-Public: (01)845225002435(17)210831(10)0301499387(90)989609001211
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131288
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 10185
• Device Catalogue Number: 400-0300.16
• Device Lot Number: 0301499387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2018
• 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
• Patient Outcome(s): Required Intervention