MAUDE Adverse Event Report: COOK INC ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Catalog Number	HPWAS-35-180
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Event is currently under investigation.
Event or Problem Description
It was reported that the hydrophilic coating on the roadrunner uniglide device appeared to be coming off of the device during the sfa intervention procedure.The reporter stated that this occurred on the distal end of the guide, away from the patient, and none of coating came off inside the patient.No harm to the patient was reported.
Additional Manufacturer Narrative
Corrected information: product code: dqx.Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One used roadrunner uniglide hydrophilic wire guide was returned for investigation.Damage is noted at the proximal end of the wire guide.The proximal end of the polymer jacket is attached , but is perpendicular to the core wire 2mm.The hydrophilic coating is present.The device outside diameter and length are within specifications.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Hydrophilic coated wire guides require 100% inspection and verifications to ensure this device meets requirements.Per the customer, the problem occurred around 10 minutes after activation.Per the ifu, "use of sterilized gauze moistened with heparinized saline solution facilitates handling the wire.Note: if movement of the wire within the device becomes diminished, remove the wire guide and reactivate the hydrophilic coating by wetting its entire surface with heparinized saline solution." there is no information regarding the preparation and handling of the device that may have contributed to the device failure.Based on the information provided, examination of the returned product, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6648158
• Report Number: 1820334-2017-01559
• Device Sequence Number: 16424906
• Product Code: DXQ
• UDI-Device Identifier: 00827002561779
• UDI-Public: (01)00827002561779(17)200424(10)7852139
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2017

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 Catalogue Number: HPWAS-35-180
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/09/2017
• Supplement Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 06/16/2017
• Supplement Report FDA Received Date: 10/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1