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

Model Number	G56173
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common name & product code = dqx wire, guide, catheter.Occupation = non-healthcare professional- distributor.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 inspection within a distribution facility, a black hair was found in the package of a roadrunner uniglide hydrophilic wire guide.The device did not make contact with any patient.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary.As reported, during inspection within a distribution facility, a black hair was found in the package of a roadrunner uniglide hydrophilic wire guide.The device did not make contact with any patient.Investigation - evaluation.Reviews of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, and quality control procedures of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.Images were provided by the distributor which show a hair-like fiber in the packaging.A document-based investigation evaluation was also conducted.A review of the device history showed no failure-related nonconforming events.It should be noted there were no other reported lot-related complaints.No gaps were discovered in the manufacturing instructions or quality control procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.There is no evidence to suggest that there are additional nonconforming devices in-house or in the field.The product is packaged with instructions for use, which state, ¿do not use the product if there is doubt as to whether the product is sterile.¿ based on the information available, investigation has concluded that a manufacturing and quality control deficiency 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.
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: 9611248
• Report Number: 1820334-2020-00172
• Device Sequence Number: 366851
• Product Code: DQX
• UDI-Device Identifier: 00827002561731
• UDI-Public: (01)00827002561731(17)220227(10)9537810
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2020

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: No Information
• Device Expiration Date: 02/27/2022
• Device Model Number: G56173
• Device Catalogue Number: HPWA-35-150
• Device Lot Number: 9537810
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 06/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1