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

Model Number	G07518
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common name & product code: dqx wire, guide, catheter.(b)(6).Occupation: unknown.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 hair-like fiber was observed within the primary packaging of a roadrunner the firm hydrophilic wire guide.The device did not make contact with any patient.
Event or Problem Description
No new patient or event information to report.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.H6: methods code desc - 5: communication/interviews (4111).Description of event: as reported, during inspection within a distribution facility, a hair-like fiber was observed within the primary packaging of a roadrunner the firm hydrophilic wire guide.The device did not make contact with any patient.Investigation ¿ evaluation.A document based investigation was performed including a review of complaint history, device history record, the instructions for use, and quality control data.The complaint device was not returned; therefore, no physical examinations could be performed.However, photos were provided of the device, and from the photos, a foreign particle can be confirmed within the sealed packaging.A review of the device history record found 2 relevant nonconformances.However, all nonconforming products were reworked, there is a 100% inspection for the reported nonconformance.A review of complaint history records shows no other complaints associated with the complaint device lot.At this time, cook did not conclude that 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 sufficient controls are in place to detect this failure mode prior to release.Cook has concluded that a quality control deficiency likely led to the reported event.Though the device was not returned, the packaging appears to be sealed with a small unknown fiber.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.

• 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: 10101464
• Report Number: 1820334-2020-01021
• Device Sequence Number: 19613568
• Product Code: DQX
• UDI-Device Identifier: 00827002075184
• UDI-Public: (01)00827002075184(17)220806(10)9900571
• Combination Product (Y/N): N
• 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): 12/29/2020

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: 08/06/2022
• Device Model Number: G07518
• Device Catalogue Number: RPC-35-180
• Device Lot Number: 9900571
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 05/29/2020
• Supplement Report FDA Received Date: 12/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1