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

Model Number	10185J
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).No tests/laboratory data 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.The customer reported during a planned diagnostic coronary procedure, inside the body, before normalization, the physician realized the tip of the manufacture's device was damaged and he had to replace it with another same product.There was no status decline, evidence of any injury or any required intervention to prevent injury.By report, the device appeared intact/in one piece upon removal from the patient.Visual and microscopic inspections were performed on the returned device.The sensor was broken and the distal portion of the sensor was missing.The probable cause for the reported "the wire of the tip was damaged" failure is damage during use.The damage likely occurred as a result of mechanical strain during procedure.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.This product problem is being submitted because a component of the device is missing and it could not be determined when the separation occurred.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: 7921187
• Report Number: 2939520-2018-00113
• Device Sequence Number: 11134017
• Product Code: DQX
• UDI-Device Identifier: 00845225002442
• UDI-Public: (01)00845225002442(17)210630(10)0301465490(90)989609001221
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/16/2018

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: 06/30/2021
• Device Model Number: 10185J
• Device Catalogue Number: 400-0300.17
• Device Lot Number: 0301465490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 09/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1