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

Model Number	G46138
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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, the user opened the package and placed a biwire nitinol hydrophilic wire guide on the operating table.The device was flushed with saline and removed from its holder.It was found that the coating of the wire guide was discontinuous and incomplete.A new guidewire was used to complete the procedure.Attached photo appears to show section of the polymer jacket missing, exposing metal wire.The device did not make patient contact.The patient did not require any additional procedures or experience any adverse effects due to this event.
Additional Manufacturer Narrative
Investigation evaluation description of event: as reported, the user opened the package and placed a biwire nitinol hydrophilic wire guide on the operating table.The device was flushed with saline and removed from its holder.It was found that the coating of the wire guide was discontinuous and incomplete.A new guidewire was used to complete the procedure.Attached photo appears to show section of the polymer jacket missing, exposing metal wire.The device did not make patient contact.The patient did not require any additional procedures or experience any adverse effects due to this event.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control (qc) procedures, a visual inspection, of the returned device, were conducted during the investigation.One biwire nitinol hydrophilic wire guide was returned in an open package with label.The wire guide holder was flushed with water.It was not possible to remove the wire guide from the holder.The difficulty removing the wire guide from the holder was not repeated by the supplier who carried out a review of the device.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 detailed below.The incoming inspection records at cook were reviewed, and the lot passed incoming inspection.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 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 instructions for use (t_hbwg2_rev1) supplied with the wire guide were reviewed and include the following: "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." it was reported the product was opened and placed on the operating table, it was pre-flushed with saline for lubrication and then the guidewire was removed.The complaint device is assembled by a supplier to cook who carried out an investigation in addition to cook.The returned complaint device was reviewed by the supplier who noted skived/cut damage in a proximal to distal orientation located 124 cm to 130.1 cm from the distal tip, exposing metallic core wire.This damage caused an overlap of approximately 6 cm of the polymer jacket material.The skive/cut damage and overlapping of the polymer jacket material indicates excessive and/or forceful manipulation of the device while attempting to remove the biwire from the dispenser hoop without proper hydration.Cook has concluded the cause of the complaint cannot 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: 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: 20243082
• Report Number: 1820334-2024-01236
• Device Sequence Number: 7301070
• Product Code: OCY
• UDI-Device Identifier: 00827002461383
• UDI-Public: (01)00827002461383(17)270305(10)71004354
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 10/11/2024

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: G46138
• Device Catalogue Number: BWS-035150
• Device Lot Number: 71004354
• 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: 08/30/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2024
• 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