MAUDE Adverse Event Report: COOK INC HIWIRE NITINOL HYDROPHILIC WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number	G30474
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation ¿ evaluation.It was originally reported that after insertion into the patient during a ureteroscopic lithotomy for kidney stone removal, the user found the tip of a hiwire nitinol hydrophilic wire guide was "uneven".Resistance was felt, "in and out".The procedure was completed by using a new unspecified wire guide.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures or experience any adverse effects due to this occurrence.Upon completion of the investigation, it was determined that the polymer jacket had separated from the wire guide.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), quality control procedures, and a supplier investigation were conducted during the investigation.A visual inspection of the returned complaint device was also conducted.The complaint device was returned to cook for investigation.A visual exam notes the tip of the wire guide is missing.The inner metal is visible.The complaint device was evaluated by the cook supplier who noted a ductile/tensile overload fracture of the polymer jacket at the proximal end, resulting in polymer jacket material loss and exposure of approximately 0.1 cm of the underlying metallic core wire.The supplier stated that based on the nature of the damage observed, the device was manipulated against resistance.The wire guide is assembled and packaged by a cook supplier.The incoming inspection records at cook were reviewed and no anomalies were identified.Additionally, 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 device history record (dhr) done by cook and the supplier found no related non-conformances reported for this failure mode.A complaint history database search showed 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 products exist either in house or in the field.Cook also reviewed product labeling; the ifu supplied with the device states the following in consideration of the reported failure mode: ¿endhole size and length of the device must be taken into consideration to ensure proper fit between wire guide and device.Instructions for activating hydrophilic coating: the hydrophilic coating on the wire guide is activated by immersion in sterile water or sterile saline solution.I.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.Based upon the available information, inspection of the returned device, review of the supplier investigation, and results of the investigation, cook has concluded that the cause for 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.
Event or Problem Description
It was originally reported that after insertion into the patient during a ureteroscopic lithotomy for kidney stone removal, the user found the tip of a hiwire nitinol hydrophilic wire guide was "uneven".Resistance was felt, "in and out".The procedure was completed by using a new unspecified wire guide.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures or experience any adverse effects due to this occurrence.Upon completion of the investigation, it was determined that the polymer jacket had separated from the wire guide.

• Brand Name: HIWIRE NITINOL 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: 23716972
• Report Number: 1820334-2025-01501
• Device Sequence Number: 8900908
• Product Code: OCY
• UDI-Device Identifier: 00827002304741
• UDI-Public: (01)00827002304741(17)271007(10)71005007
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/04/2025

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: G30474
• Device Catalogue Number: HWS-035150
• Device Lot Number: 71005007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PUSEN: SINGLE-USE ELECTRONIC URETERORENOSCOPIC CAT
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic