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

Model Number	G56177
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common name & product code = dqx wire, guide, catheter.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
As reported, during an angioplasty and atherectomy on the right leg via groin access, the coating of a roadrunner uniglide hydrophilic wire guide separated from the device.The device was activated using saline and was used three times during the procedure before the coating separated, which occurred between uses, outside of the patient.The device was kept hydrated between uses and reactivated before each use.Another device of the same type was used to successfully complete the procedure.No part of the device remained inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Description of event: as reported, during an angioplasty and atherectomy on the right leg via groin access, the coating of a roadrunner uniglide hydrophilic wire guide separated from the device.The device was activated using saline and was used three times during the procedure before the coating separated, which occurred between uses, outside of the patient.The device was kept hydrated between uses and reactivated before each use.Another device of the same type was used to successfully complete the procedure.Investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record, the instructions for use, manufacturing instructions, quality control data, and specifications.The complainant returned one, used hpwas-35-180 wire to cook for investigation.Physical examination of the returned device showed no damage to the polymer jacket.The wire was activated with water, resulting in a lubricious hydrophilic coating.This is not consistent with the reported failure mode.A review of the device history record found four non-conformances related to the reported failure mode.The non-conformances were for surface defect of the wire guide in which all affected devices were scrapped.Although these non-conformances are relevant to the reported failure mode, there are 100% inspections to capture this non-conformance.A review of complaint history records shows no other complaints associated with the complaint device lot.As adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints have been received from the field, it was concluded that there is no evidence that non-conforming product exists in house or in field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions: 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.A catheter, introducer sheath or vessel dilator should replace the needle as soon as the wire guide has been inserted in the vessel.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.¿ instructions for use.Wire guide use: 2.When wet with saline solution or blood, the hydrophilic wire guide will become lubricious.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 guides and reactivate the hydrophilic coating be wetting its entire surface with heparinized saline solution.¿ after use: 1.Excess blood can be removed from the wire guide by wiping the surface once or twice with gauze moistened with heparinized saline solution.Do not use dry gauze as this may damage the wire surface resulting in increased resistance when the wire is reinserted into the device.2.Use of alcohol, antiseptic solutions or other solvents must be avoided, because they may adversely affect the surface of the hydrophilic wire guide.3.After cleaning the wire, replace it by its proximal end into its dispenser filled with heparinized saline solution.This wire guide can only be used during the same procedure on the same patient.4.Upon reinsertion into the device, if the wire guide does not move initial ease, exchange it for a new uniglidetm hydrophilic wire guide.¿ a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Based on the information provided, inspection of the returned device, and the results of the investigation, a potential root cause for this event has been traced to unintended use error.Cook has concluded operational factors likely contributed to this incident as physical examination of the returned device showed no damage to the device polymer jacket and the hydrophilic coating was lubricious when activated.The ifu precautions the user not to use alcohol, antiseptic solutions, or other solvents and not to use dry gauze to removed excess blood between uses as it may adversely affect the surface of the hydrophilic wire guide.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.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.
Event or Problem Description
No new patient or event information to report.

• 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: 11387124
• Report Number: 1820334-2021-00395
• Device Sequence Number: 11771462
• Product Code: DXQ
• UDI-Device Identifier: 00827002561779
• UDI-Public: (01)00827002561779(17)231030(10)13514814
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K110009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 07/16/2021

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: 10/30/2023
• Device Model Number: G56177
• Device Catalogue Number: HPWAS-35-180
• Device Lot Number: 13514814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1