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

Model Number	G18154
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
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 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 "sheath" from a roadrunner the firm hydrophilic wire guide detached.As there is no "sheath" on this device, our understanding of the issue is that the polymer jacket separated from the wire guide.The issue was discovered upon the customer receiving the device and there was no patient involvement.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Corrected information: d4.Investigation ¿ evaluation: event description: as reported, the "sheath" from a roadrunner the firm hydrophilic wire guide detached.As there is no "sheath" on this device, our understanding of the issue is that the polymer jacket separated from the wire guide.The issue was discovered upon the customer receiving the device and there was no patient involvement.One roadrunner the firm hydrophilic wire guidewire jacket was returned for investigation in an open package with product label.The wire guide was observed to have an indentation in the jacket at the distal end, the wire guide appears to have been scrapped.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 dhr for the reported complaint device lot revealed no recorded non conformances relevant to the failure mode.A complaint history search did not identify any other events associated with the reported 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.The product ifu contains the following information related to the reported failure mode: precautions : ¿ manipulation of the wire guide requires appropriate imaging use caution not to force or over manipulate the wire guide when gaining access.¿ when a wire guide through a metal cannula/needle, use caution as damage may to the outer coating.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.Cook has concluded a cause of the complaint 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.

• 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: 19054668
• Report Number: 1820334-2024-00479
• Device Sequence Number: 6992460
• Product Code: OCY
• UDI-Device Identifier: 00827002181540
• UDI-Public: (01)00827002181540(17)260419(10)15398115
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2024

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 Expiration Date: 04/19/2026
• Device Model Number: G18154
• Device Catalogue Number: RPC-035145
• Device Lot Number: 15398115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2023
• 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: Unknown