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

Catalog Number	HPWAS-35-180
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number = dqx.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported, the tip of a roadrunner uniglide hydrophilic wire guide broke during a peritoneal dialysis catheter placement.No patient adverse effect has been reported.Although requested, additional event details, patient demographics and outcome has not been provided.Should additional information become available, a follow up report will be submitted.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), quality control, and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.However, it should be noted that three subassembly lots were reviewed, and several nonconformances related to the device failure were noted.For subassembly lot sa8528334, 28 nonconformances were noted, 4 for surface defects, and 24 for hc-uv coating.For subassembly lot sa8528331, 3 nonconformances were noted, 1 for exposing wire, and 2 for surface defects.Finally, for subassembly lot sa8528335 a total of (b)(4) nonconformances were noted, 8 for inadequate tips, and 6 for grinded through tips.All of these subassembly nonconformances were scrapped, and not replaced prior to order completion.It also should be noted there were no other reported complaints for the original lot number (8705802).Additionally, an ifu is provided with this device, which states that the intended use of this product is for facilitating the delivery of percutaneous catheters into the peripheral vasculature.Furthermore, it is not known if resistance occurred during the procedure.The roadrunner uniglide wire guide is packaged with ifu t_hpw.T_hpw states, ¿if resistance is felt during device placement, discontinue the procedure and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, remove the wire guide and device as a unit to prevent possible damage and/or complications.¿ it was not known if the device was manipulated in a needle or cannula.Per the ifu, ¿avoid manipulating or withdrawing the hydrophilic wire guide back through a metal needle or cannula.A sharp edge may scrape the coating or shear the wire guide.¿ it is not known if the device may have been torqued.The ifu states, "it is recommended that a plastic torque device be used to handle the hydrophilic wire guide.Use of a metal torque device may damage the wire.¿ based on the information provided, no product returned and the results of our investigation, a definitive root cause can be traced to the user.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 7956890
• Report Number: 1820334-2018-02430
• Device Sequence Number: 148853
• Product Code: DQX
• UDI-Device Identifier: 00827002561779
• UDI-Public: (01)00827002561779(17)210402(10)8705802
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K110009
• 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): 11/06/2018

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: 04/02/2021
• Device Catalogue Number: HPWAS-35-180
• Device Lot Number: 8705802
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1