MAUDE Adverse Event Report: VOLCANO CORPORATION PRIMEWIRE PRESTIGE PLUS PRESSURE GUIDE WIRE; WIRE, GUIDE, CATHETER

Model Number	9185J
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.The customer reported that during procedure error code "attach wire to connector" was received.The device was visually and microscopically inspected and damage was observed.The pressure sensor was broken and the distal portion was missing.The wire was not recognized during zero testing.The probable cause of the reported failure is an electrical failure with the wire.The device was observed to have a broken sensor, which is consistent with the reported failure.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.This product problem is being reported because a portion of the sensor is missing from the device, it could not conclusively be determined when the separation occurred.There is a potential for harm if the malfunction were to recur.

• Brand Name: PRIMEWIRE PRESTIGE PLUS PRESSURE GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 8100314
• Report Number: 2939520-2018-00182
• Device Sequence Number: 2140871
• Product Code: DQX
• UDI-Device Identifier: 00845225001117
• UDI-Public: (01)00845225001117(17)190831
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K111395
• 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): 08/08/2018

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: 08/31/2019
• Device Model Number: 9185J
• Device Catalogue Number: 400-0300.04
• Device Lot Number: 0111 50075481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 11/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1