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

Model Number	10185
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts to obtain patient information have been unsuccessful.Facility declined to provide the information.No tests/laboratory data was available.Other relevant history: no information was available.The implant or explant dates are not applicable to this device.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to the alleged death or deterioration in the state of the health of any person.
Event or Problem Description
This case was reviewed and investigated according to the manufacturer's policy.It was reported, inside the body, after normalization, prior to measurement, the pd curve disappeared.Additional information provided, the device was inserted into the patient once.No additional intervention was performed, there was no patient status decline nor patient injury.No resistance was experienced during the procedure.No damage was observed prior to the procedure and the device is reported to have been intact and in one piece upon removal from the patient.A second of the same make and model of the manufacturer's device was used to successfully complete the procedure.Visual and microscopic inspection and functional testing were performed on the returned device.The core wire was broken and a portion missing; no core wire was observed past the pressure sensor housing.A portion of the distal coil was missing.The remaining distal coil was stretched.The pressure sensor was intact.The device passed zero testing.Drift testing was not performed since the wire was damaged.The probable cause of the reported signal/connection failure could not be determined.The device passed zero testing and drift testing could not be performed since the device was returned damaged.The probable cause of the core wire and distal coil separation could not be determined.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.This event is being submitted as there is a potential for harm if the malfunction were to recur.

• Brand Name: VERRATA PRESSURE GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 7644142
• Report Number: 2939520-2018-00059
• Device Sequence Number: 2044117
• Product Code: DQX
• UDI-Device Identifier: 00845225002435
• UDI-Public: (01)00845225002435(17)210228
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/29/2018

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
• Operator of Device: Physician
• Device Expiration Date: 02/28/2021
• Device Model Number: 10185
• Device Catalogue Number: 400-0300.16
• Device Lot Number: 0243 50132286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1