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

Model Number	10185
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference: (b)(4).Attempts to obtain patient information have been unsuccessful.Facility declined to provide the information.No tests/laboratory data was available.The implant or explant dates are not applicable to this device.
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, inside the body, before normalization, the user tried to fix the manufacturer's device at (the) usual position in the connector but it could not be caught.The device was reconnected but the problem was not solved.Additional information was provided, the device had been inspected prior to the procedure with no visible defects observed.Post procedure, the device was observed to have damage at the connection to the connector.Reportedly, no portions of the device separated or detached within the patient.A second of the same make and model of the manufacturer's device was used to successfully complete the procedure.There was no patient injury and no adverse event.Visual and microscopic inspection were performed on the returned device.The proximal conductive band and its locking core were separated and missing.The probable cause of the reported failure was damaged during use, as evidenced by the missing proximal conductive band and locking core.Manipulation and strain on the device can cause damage to components and result in the reported failure.We were unable to conclusively determine when and how the damage occurred.The instructions for use (ifu) warns, "do not flex the proximal (electrical connector) end of the device when not inserted in the connector.Excessive flexing can damage or break the internal components".The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria this event is being reported 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: 7741605
• Report Number: 2939520-2018-00076
• Device Sequence Number: 1050871
• Product Code: DQX
• UDI-Device Identifier: 00845225002435
• UDI-Public: (01)00845225002435(17)210531(10)0301440128(90)989609001211
• 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): 07/02/2018

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: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: 10185
• Device Catalogue Number: 400-0300.16
• Device Lot Number: 0301440128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2018
• Initial Report FDA Received Date: 08/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1