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

Model Number	G30474
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1-phone: (b)(6).H3: device has been returned, and preliminary evaluation has been performed, however, our investigation is ongoing, and device evaluation summary will be included in our follow up report once our investigation has been completed.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 prior to patient contact; the wire guide coating was activated prior to removal from the holder by injecting saline solution and waiting for 1 minute.The user felt the hiwire nitinol hydrophilic wire guide lubrication was not enough and with burrs.The burr did not damage the surface of the wire guide.The user changed to another same type device to complete the procedure.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event description: it was initially reported, prior to patient contact; the wire guide coating was activated prior to removal from the holder by injecting saline solution and waiting for 1 minute.The user felt the hiwire nitinol hydrophilic wire guide lubrication was not enough and with burrs.The burr did not damage the surface of the wire guide.The user changed to another same type device to complete the procedure.Upon inspection of the returned device, the cook supplier found the wire guide damaged, skived/cut, exposing the metallic core wire.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.Investigation ¿ evaluation a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record (dhr), the instructions for use (ifu), and quality control procedures.One hiwire nitinol hydrophilic wire guide was returned in an opened labelled package.The wire guide appeared to be sticking to the product protector.After flushing with blood-bank saline, a visual and tactile examination of the returned device was conducted.The customer provided description of ¿burr¿ was not detected.However, the device was found to be damaged, skived/cut in a proximal to distal orientation located 22cm to 34.5 cm from the distal tip, exposing the metallic core wire.Except where noted, the device appeared visually and dimensionally correct.The wire guide is assembled and packaged by a cook supplier.The incoming inspection records at cook were reviewed and the lot passed incoming inspection.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 found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Based on the available information, cook has concluded that the device was manufactured to specification and there is no evidence suggesting nonconforming product exists either in house or in the field.Cook also reviewed product labeling.The ifu [t_hbwg2_rev1] packaged with the device contains the following in relation to the reported failure mode: "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 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 on the information provided, inspection of the returned device, and the results of the investigation, a specific cause of the complaint could not be established.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified, and we will continue to monitor 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: 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: 21989095
• Report Number: 1820334-2025-00495
• Device Sequence Number: 11884032
• Product Code: OCY
• UDI-Device Identifier: 00827002304741
• UDI-Public: (01)00827002304741(17)270526(10)71004687
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K082536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

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: 71004687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2024
• 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
• Patient Sex: Unknown