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

Catalog Number	HPWAS-35-320
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code = dqx.(b)(4).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, upon removal of the roadrunner uniglide hydrophilic wire guide from the cxi catheter, it's hydrophilic coating was observed to be stripped off and clumped on the wire.The complaint device had been used during treatment of a superficial femoral artery (sfa) occlusion via access in the right groin.The procedure had been completed successfully at the time of this occurrence.Per the complainant, the hydrophilic coating had been activated for approximately five to 10 minutes prior to use.Powder-free latex gloves were used.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.A review of the complaint history, device history record, documentation, instructions for use (ifu), manufactures instructions, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the device had a 3mm long polymer protrusion noted at 148.1cm from the proximal end.Hydrophilic coating was present.Additionally, 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 showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.However, the sub assembly lot (sa8001891) was reviewed and noted 5 nonconformances (11 devices) related to the device failure.There were 2 devices related to polymer defect and relevant to the device failure.There were 4 devices related to surface defect and not relevant to the device failure.There were 2 wires related to twisted wires and relevant to the device failure.There were 3 devices related to inadequate, missing or incomplete tip/taper and is not relevant to the device failure.However, these devices were scrapped and not replaced.Moreover, the component device supplier evaluation stated ¿the investigation for (b)(4)has been completed.Based on an evaluation of the photographs provided, the defect is not consistent with the surface defects inherent to the manufacturing process at the supplier.This damage appears to have occurred after inspection, as this defect would have failed the ring gage inspection.A review of the executed lot records revealed no anomalies in the processing of the parts that are inconsistent with historical runs.¿ furthermore, an ifu is provided with the device which states ¿upon removal from package, inspect the product to ensure no damage has occurred.".The physician noted something ¿unusual¿ with the wire prior to use and proceeded to use the same device.It is not known if the polymer coating protrusion noted during the device failure analysis worsened during use of the device.It is not known the wire had been used with a metal needle or cannula.The ifu also states to "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." based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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: 7748341
• Report Number: 1820334-2018-02326
• Device Sequence Number: 13930301
• Product Code: DQX
• UDI-Device Identifier: 00827002305076
• UDI-Public: (01)00827002305076(17)200906(10)8193803
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2018

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: 09/06/2020
• Device Catalogue Number: HPWAS-35-320
• Device Lot Number: 8193803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CXI CATHETER