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

Model Number	G46138
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the biwire nitinol hydrophilic wire guide broke during an unspecified procedure.The device was removed and the procedure was completed by using another same-like device.As reported, the patient did not experience any adverse effects.Additional information has been requested but has not yet been received.
Additional Manufacturer Narrative
E1 - initial reporter establishment name: (b)(6).H3: device evaluation is 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
Additional information received on 30oct2025: the entire polymer jacket is missing; the wire guide was not broken.The issue was found prior to patient contact.The procedure was completed by using another same-like device.
Additional Manufacturer Narrative
Additional information: b5.Correction: annex a, d4, f and g.Investigation ¿ evaluation: it was reported that the biwire nitinol hydrophilic wire guide broke during an unspecified procedure.The device was removed and the procedure was completed by using another same-like device.As reported, the patient did not experience any adverse effects.Additional information received the entire polymer jacket is missing, the wire guide was not broken.The issue was found prior to patient contact.The procedure was completed by using another same-like device.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturer¿s instructions (mi), and quality control (qc) procedures were conducted during the investigation.Functional tests and visual inspection of the returned complaint device was also conducted.The wire guide was returned for investigation in open package with label.A visual exam noted 9 mm of the wire guide jacket is missing from the tip exposing the metal.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) was completed by a supplier.The wire guide is assembled and packaged by supplier.The incoming inspection records at cook were reviewed and the lot passed incoming inspection.No related non-conformances reported for lot.A complaint history database search showed one other similar related complaint associated with the failure mode.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 supplied with the device states the following in consideration of 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.The device is assembled by a supplier who upon flushing the dispenser hoop with blood-bank saline, was able to remove the wire guide was easily.The supplier also noted wire guide presented a ductile/tensile overload fracture of the polymer jacket with material removal, exposing 1.0 cm of the metallic core wire at the proximal end; the polymer jacket material of the fracture was not returned with the specimen.The supplier concluded based on the nature of the damage observed, the device was manipulated against resistance.Based upon the available information, inspection of the returned device, 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.

• Brand Name: BIWIRE 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: 23351363
• Report Number: 1820334-2025-01281
• Device Sequence Number: 12959660
• Product Code: OCY
• UDI-Device Identifier: 00827002461383
• UDI-Public: (01)00827002461383(17)271120(10)71005080
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 11/18/2025

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: G46138
• Device Catalogue Number: BWS-035150
• Device Lot Number: 71005080
• 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: 09/28/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2024
• 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