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

Model Number	G09105
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common name & product code = dqx wire, guide, catheter.Initial reporter: 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 at a distribution facility, foreign matter described as a "strange particle" was found inside the unopened package of a roadrunner the firm hydrophilic wire guide.The device did not make contact with any patient.
Additional Manufacturer Narrative
Investigation - evaluation.A review of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, photos were provided and a document-based investigation evaluation was performed.A review of the device history record shows one nonconforming event which could contribute to this failure mode; however, the package of that effected unit was reworked prior to completion of the work order.It should also be noted there were no other reported complaints for this lot number.Furthermore, a review of the manufactures instructions and quality control procedures was conducted, and no gaps were discovered.The instructions for use included with this device instruct the user ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, no product returned and the results of our investigation, this event can be traced to manufacturing and quality control deficiencies.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 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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 THE FIRM HYDROPHILIC WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8969459
• Report Number: 1820334-2019-02246
• Device Sequence Number: 3079697
• Product Code: DQX
• UDI-Device Identifier: 00827002091054
• UDI-Public: (01)00827002091054(17)220423(10)NS9670058
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K901899
• 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): 01/08/2020

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: 04/23/2022
• Device Model Number: G09105
• Device Catalogue Number: RPC-35-260
• Device Lot Number: NS9670058
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1