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

Model Number	G30492
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common name & product code = dqx wire, guide, catheter.(b)(6).Occupation = quality engineer 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 procedure, a "white foam" was found on a roadrunner uniglide hydrophilic wire guide upon opening the package of the device.The user did not attempt to activate the hydrophilic coating.The wire guide had not come into contact with moisture.The coating was not flaking or coming off the device.The package was in good condition and was stored per the requirements of the facility.The device did not make patient contact.Another device of the same type was used to complete the procedure.There has been no report that the patient experienced any adverse effects due to this event.
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.Initial report as reported, during an angioplasty procedure, a "white foam" was found on a roadrunner uniglide hydrophilic wire guide upon opening the package of the device.The user did not attempt to activate the hydrophilic coating.The wire guide had not come into contact with moisture.The coating was not flaking or coming off the device.The package was in good condition and was stored per the requirements of the facility.The device did not make patient contact.Another device of the same type was used to complete the procedure.There has been no report that the patient experienced any adverse effects due to this event.Investigation ¿ evaluation.Reviews of the complaint history, device history record, instructions for use (ifu), quality control procedures, specifications, and a visual inspection of the returned device were conducted during the investigation.One wire guide was returned opened but undamaged.Visual inspection found two small patches of an unknown white fuzz on the wire guide surface.Additionally, a document-based investigation evaluation was performed.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Since there are no related nonconformances or other complaints from this lot, there is no evidence that nonconforming product exists in house or in the field.Furthermore, a review of the quality control procedures was conducted, and no gaps were discovered.The ifu provided with this device states ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ it is unknown at what point foreign matter appeared on the device.It is possible that the foreign matter was introduced during manufacturing and subsequent quality control inspection procedures did not catch this specific occurrence, but this cannot be confirmed since the complaint device was returned already opened.Cook has concluded that a manufacturing cause of failure potentially contributed to this incident.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.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: 9916971
• Report Number: 1820334-2020-00738
• Device Sequence Number: 11587292
• Product Code: DQX
• UDI-Device Identifier: 00827002304925
• UDI-Public: (01)00827002304925(17)220410(10)NS9642593
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K130766
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2020

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: 04/10/2022
• Device Model Number: G30492
• Device Catalogue Number: HPWA-35-260
• Device Lot Number: NS9642593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2020
• Initial Date Received by Manufacturer: 03/27/2020
• Supplement Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 06/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 46