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

Model Number	10185
Medical Device Problem Code	Material Distortion (2977)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This case was reviewed and investigated according to the manufacturer's policy.The customer declined to provide patient information.No damage was observed during prep.Resistance was felt during the procedure.The device was removed by itself, not as a system.Treatment was completed by the procedure.No tests/laboratory data was available.Other relevant data: no information was available.The implant or explant dates are not applicable to this device.Visual and microscopic inspection were performed on the returned device.The entirety of the wire was intact.The distal tip was wavy and the distal coil was stretched and bunched.This damage likely occurred as a result of mechanical strain during the procedure while the user attempted to free the device from being stuck.Per user report, during crossing the lesion, the device became stuck in a small branch.Another device was used to remove the wire.Damage to the device is consistent with the reported failure.Unfortunately, we were unable to conclusively determine how the device initially became stuck.Instructions for use (ifu) warns to never advance, torque or retract a pressure guide wire which meets significant resistance.The ifu also cautions the pressure guide wire should not be advanced if resistance is encountered.The wire should never be forcibly pushed into a vessel.Any time that resistance is encountered, the wire should be withdrawn under fluoroscopic guidance.In some instances, the wire may kink and must be removed.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.There were no nonconforming material reports or deviations noted that would contribute to the reported failure mode.This complaint will be monitored as part of complaint data analysis.
Event or Problem Description
It was reported that during a coronary procedure, when crossing the lesion inside the body some resistance was met and the wire got stuck in a small branch.Another manufacturers wire was used and the [manufacturer's] wire could remove from the body.There was no patient injury.Patient released as expected in stable condition.Vessel: rca#3, artery occlusion: 50%, tortuousness: slightly.This event is being reported because additional intervention was performed in an attempt to remove the device.

• 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: 7152201
• Report Number: 2939520-2017-00096
• Device Sequence Number: 18871426
• Product Code: DQX
• UDI-Device Identifier: 00845225002435
• UDI-Public: (01)00845225002435(17)200930
• 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): 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 09/30/2020
• Device Model Number: 10185
• Device Catalogue Number: 400-0300.16
• Device Lot Number: 0243 50116192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 12/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention