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

Model Number	G30474
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: name and address: postal code: (b)(6).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
As reported, a hiwire nitinol hydrophilic wire guide broke in the middle, into two pieces, while removing it from the wire guide holder.Some contrast agent and water mixture was applied to the holder to activate the coating.The device was not used on the patient.The procedure was complete with another wire guide.The patient did not require any additional intervention and did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Description of event: as reported, a hiwire nitinol hydrophilic wire guide broke in the middle, into two pieces, while removing it from the wire guide holder.Some contrast agent and water mixture were applied after the user removed from the holder to activate the coating.The device was not used on the patient.The procedure was complete with another wire guide.The patient did not require any additional intervention and did not experience any adverse effects due to this occurrence.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control (qc) procedures, and a visual inspection of the returned device, were conducted during the investigation.One hiwire nitinol hydrophilic wire guide was returned in an open package with label.The wire guide was returned in 2 pieces (total length 150.6centimeters short piece was 44centimeters and the longer piece was 106.6centimeters).At the break it does not appear to be a clean break and looks like it was pulled apart.The complaint device is assembled by a cook supplier, who carried out an investigation in addition to cook.The returned complaint device was reviewed by the supplier who noted the specimen presented a ductile, tensile overload fracture of the guidewire at 44cm from the distal tip.Except where noted, the specimen device appeared visually and dimensionally correct.The supplier also indicated the damage appeared like exerting excessive force while attempting to remove the wire guide from a dispenser that has not been properly hydrated.However, it was reported the coating of the wire guide coating was activated prior to attempting to remove it from the holder.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.The wire guide is assembled and packaged by a supplier who completed a dhr review as part of their investigation.The incoming inspection records at cook were reviewed and the lot passed incoming inspection.A review of the device history record (dhr) 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.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence from cook and supplier investigation, indicate that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that that the device was manufactured to specification and there is no evidence that nonconforming product exists in house or in the field.The wire guide was supplied with ifu which includes the following.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).Cook has concluded that the cause for the complaint could not be established.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering 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: 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: 19766816
• Report Number: 1820334-2024-00968
• Device Sequence Number: 15581829
• Product Code: OCY
• UDI-Device Identifier: 00827002304741
• UDI-Public: (01)00827002304741(17)261226(10)71004342
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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
• Report Date (Section B): 10/08/2024

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
• Operator of Device: Health Professional
• Device Model Number: G30474
• Device Catalogue Number: HWS-035150
• Device Lot Number: 71004342
• 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: 07/05/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2023
• 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