MAUDE Adverse Event Report: COOK INC ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE; OCY, ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number	G18154
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: phone: (b)(6).H3: 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.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
It was reported during a flexible ureteroscopy with laser lithotripsy, that when the roadrunner the firm hydrophilic wire guide was being passed, it was evident that the tip was frayed, so it was decided to use a new guide to finish the procedure.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.The patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.
Event or Problem Description
Additional information was received 27nov2025.The coating of the wire guide was activated by hydration in sterile saline solution prior to removal from the holder following the usual protocol.During the initial advancement of the wire guide through the canal, slight resistance was observed.When the wire guide was partially withdrawn to check its condition, the tip was noted to be frayed.Therefore, the use of the device was suspended and replaced with a new wire guide.The damage to the tip was detected before the guide came into direct contact with the patient.There was no separation of any components inside the patient.Only the endoscope corresponding to the procedure was being used.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5, d4 - primary udi number.Correction: h6 - annex g.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: d9, h3 (device not returned), h6 (annex g) investigation ¿ evaluation it was reported during a flexible ureteroscopy with laser lithotripsy, that when the roadrunner the firm hydrophilic wire guide was being passed, it was evident that the tip was frayed, so it was decided to use a new guide to finish the procedure.The coating of the wire guide was activated by hydration in sterile saline solution prior to removal from the holder following the usual protocol.During the initial advancement of the wire guide through the canal, slight resistance was observed.When the wire guide was partially withdrawn to check its condition, the tip was noted to be frayed.Therefore, the use of the device was suspended and replaced with a new wire guide.The damage to the tip was detected before the guide came into direct contact with the patient.There was no separation of any components inside the patient.Only the endoscope corresponding to the procedure was being used.The patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, specifications, and instructions for use (ifu) were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhrs for the reported complaint device lot and the related subassembly lots revealed no recorded discrepancies relevant to the failure mode.A review of complaint history records found no other related complaints associated with the failure mode for the complaint device lot.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook also reviewed product labeling.The ifu packaged with the device contains the following in relation to the reported failure mode: precautions ¿ manipulation of wire guide requires appropriate imaging control.Use caution not to force or over manipulate the wire guides when gaining access.Instructions for activating hydrophilic coating: the hydrophilic coating on the wire guide is activated by immersion in sterile water or sterile saline solution.1.Prior to using the wire guide, fill a syringe with sterile water or sterile saline solution and attach it to the flushing port on the wire guide.2.Inject enough solution to wet the wire guide surface entirely.This will activate the hydrophilic coating.¿ for roadrunner@ pc wire guide double flexible, the pink end of wire guide is not hydrophilically coated or intended for insertion into body.Based on the information provided, no product returned, and the results of the investigation, a potential cause for this event could not be established.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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: OCY, ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• 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: 23346195
• Report Number: 1820334-2025-01267
• Device Sequence Number: 9544376
• Product Code: OCY
• UDI-Device Identifier: 00827002181540
• UDI-Public: (01)00827002181540(17)280207(10)16456578
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K082536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2026

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
• Operator of Device: Health Professional
• Device Model Number: G18154
• Device Catalogue Number: RPC-035145
• Device Lot Number: 16456578
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 11/27/2025; 03/12/2026
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/02/2025; 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male