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

Model Number	G06866
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.H3: device evaluated by mfg = device evaluation anticipated but not yet begun 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 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
As reported, the packaging of two units of 'roadrunner the firm lt hydrophilic wire guide' are broken.The issue was noted during device inspection within a distribution facility, therefore, there is no patient involvement.
Additional Manufacturer Narrative
Correction: h6, annex a.Summary of event: as reported, the packaging of two units of 'roadrunner the firm lt hydrophilic wire guide' are broken.The issue was noted during device inspection within a distribution facility, therefore, there is no patient involvement.Investigation evaluation: reviews of the complaint history, device history record (dhr), and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.Two devices were returned in unused condition to cook for investigation.One package was confirmed to be damaged (a hole in the package), while the second package shows signs of damage to the packaging, but no punctures were noted.A document-based investigation evaluation was performed.A review of the device history record and complaint history found no discrepancies or additional complaints on the final lot.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon evidence provided by the complaint facility, review of the returned device, complaint file, dmr, and dhr suggests that there is evidence that the device was manufactured to specification.Based on the information provided and the results of the investigation, cook concluded that shipping/handling contributed to this incident.The customer reported that two devices had broken packaging; however, upon return, only one device packaging was identified to have a hole.Therefore, cook confirmed only one device.The risk analysis for this failure mode was reviewed, and no additional escalation was required.The appropriate personnel have been notified, and cook will continue to monitor for similar events.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 LT HYDROPHILIC WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 23581697
• Report Number: 1820334-2025-01421
• Device Sequence Number: 9398245
• Product Code: DQX
• UDI-Device Identifier: 00827002068667
• UDI-Public: (01)00827002068667(17)271212(10)16378560
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K182985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

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
• Device Model Number: G06866
• Device Catalogue Number: RLPC-35-145
• Device Lot Number: 16378560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown