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

Model Number	N/A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that during a diagnostic angiogram with intervention using a roadrunner uniglide hydrophilic wire guide, the hydrophilic coating on the wire was peeling away (but not peeling off the wire) on multiple spots of the wire.This event occurred with two wires, both devices were from the same lot number.A third was opened and used to complete the procedure.No unintended section of the device remained inside the patient's body nor did the patient require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Corrected information: common device name: dqx.Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One used and damaged roadrunner uniglide hydrophilic wire guide was returned for investigation.4mm of the wire guide polymer jacket was cut but, still attached at approximately 63.7cm from the distal end, no additional damage was noted.Approximately 80% congo red was present on the device.The length of the device was within specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode and there is no evidence to suggest the product was not manufactured to current specifications.Review of the subassembly lots showed two nonconformance's that may contribute to this failure mode; however, all nonconforming product was scrapped.There were no other reported complaints for this lot number.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: 6606218
• Report Number: 1820334-2017-01291
• Device Sequence Number: 606179
• Product Code: DXQ
• UDI-Device Identifier: 00827002304932
• UDI-Public: (01)00827002304932(17)181006(10)6259460
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K130766
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2017

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 Model Number: N/A
• Device Catalogue Number: HPWA-35-320
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/05/2017
• Supplement Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 06/01/2017
• Supplement Report FDA Received Date: 11/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1