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	01/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference: (b)(4).Attempts to obtain patient information have been unsuccessful.Facility declined to provide patient information.The implant or explant dates are not applicable to this device.State/prefecture 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 pd curve disappeared on the manufacture¿s device before normalization.Another same manufacture¿s product was used to complete the procedure.There is no patient injury.Radial access.By report, no damage was observed to the device and no resistance was encountered.The returned device was visually and microscopically inspected and damage was observed.The wire had multiple kinks, the sensor was broken and a portion of the pressure sensor was missing.The probable cause of the damage could be caused by rough handling of the device during procedure as evidenced in the several bents in the distal coil.We were unable to conclusively determine when and how the damage occurred.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.This submission is being reported because the sensor was missing from the manufacture¿s device.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): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 8507307
• Report Number: 2939520-2019-00029
• Device Sequence Number: 1651167
• Product Code: DQX
• UDI-Device Identifier: 00845225002435
• UDI-Public: (01)00845225002435(17)211031(10)0301537881(90)989609001211
• Combination Product (Y/N): Y
• 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): 01/16/2019
• 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: 10/31/2021
• Device Model Number: 10185
• Device Catalogue Number: 400-0300.16
• Device Lot Number: 0301537881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• 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: 03/20/2019
• Initial Report FDA Received Date: 04/11/2019
• 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