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

Model Number	10185
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference: (b)(4).Facility declined to provide patient information of patient id, gender, age and weight.The implant or explant dates are not applicable to this device.Device not returned to manufacturer for analysis.Concomitant medical products: no information available.State is (b)(6).
Event or Problem Description
This case was reviewed and investigated according to the manufacturer¿s policy.It was reported during a planned diagnostic coronary procedure the tip of the sensor was broken.There is no patient injury.By report, the device was intact upon removal from the patient.Another pressure wire was used to complete the procedure.The device was discarded at the facility and not returned for analysis.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.This product problem is being submitted in an abundance of caution as it could not be determined where or when the alleged separation occurred.There is a potential for harm if the alleged separation were to recur.

• Brand Name: VERRATA PRESSURE GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 8344686
• Report Number: 2939520-2019-00021
• Device Sequence Number: 1098446
• Product Code: DQX
• UDI-Device Identifier: 00845225002435
• UDI-Public: (01)00845225002435(17)210630(10)0301465955(90)989609001211
• Combination Product (Y/N): Y
• Initial Reporter Country: SF
• PMA/510(K) Number: K131288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/24/2019
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 10185
• Device Catalogue Number: 400-0300.16
• Device Lot Number: 0301465955
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 02/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005