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

Model Number	G09105
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Name and address: phone: (b)(6).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, upon receipt and inspection of a roadrunner the firm hydrophilic wire guide a strange particle was found inside the primary packaging of the device.There was no patient involvement.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: as reported, upon receipt and inspection of a roadrunner the firm hydrophilic wire guide a strange particle was found inside the primary packaging of the device.Investigation ¿ evaluation a document based investigation was performed including a review of complaint history, device history record (dhr), the instructions for use, and quality control data.The complainant did not return the complaint device to cook for investigation.However, photos of the device were provided by the customer.From the photos received, the foreign matter was confirmed within the sealed packaging.From the photo review, the device was confirmed manufactured out of specification.The dhr for the reported lot number records one relevant non-conformance; ¿foreign matter, loose¿ however, all nonconforming product was reworked, the product goes through 100% inspections for the reported nonconformance, and no additional complaints have been received from the reported lot from the field.At this time, cook concluded that no nonconforming product from this lot exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied: ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ 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.Cook has concluded a manufacturing/quality control deficiency contributed to this incident.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.
Additional Manufacturer Narrative
This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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 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: 11628835
• Report Number: 1820334-2021-01087
• Device Sequence Number: 4662387
• Product Code: DQX
• UDI-Device Identifier: 00827002091054
• UDI-Public: (01)00827002091054(17)231116(10)13536332
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 06/03/2021

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: No Information
• Device Expiration Date: 11/16/2023
• Device Model Number: G09105
• Device Catalogue Number: RPC-35-260
• Device Lot Number: 13536332
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 04/09/2021; 05/05/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 04/26/2021; 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1