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

Catalog Number	HPWAS-35-260
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This mdr is being filed after the associated complaint was reviewed under remediation protocol cap (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
It was reported that the torque device caused damage to multiple locations on the wire¿s hydrophilic coating.The procedure was continued with another device, and there were no injuries or additional procedures reported.It was further confirmed that the coating was damaged.

• 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: 7894471
• Report Number: 1820334-2018-02977
• Device Sequence Number: 19180951
• Product Code: DQX
• UDI-Device Identifier: 00827002305069
• UDI-Public: (01)00827002305069(17)190331(10)6854999
• Combination Product (Y/N): N
• 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): 09/20/2018

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: 03/31/2019
• Device Catalogue Number: HPWAS-35-260
• Device Lot Number: 6854999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 78