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

Model Number	G30475
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, upon opening the packaging of a hiwire nitinol hydrophilic wire guide, the coating was damaged approximately 5 centimeters along the device.A photo provided shows the coating peeled/separated from the wire in several locations.This occurred prior to patient contact; there was no impact to the patient.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event description: as reported, upon opening the packaging of a hiwire nitinol hydrophilic wire guide, the coating was damaged approximately 5 centimeters along the device.A photo provided shows the coating peeled/separated from the wire in several locations.A new device was used to complete the procedure.This occurred prior to patient contact; there was no impact to the patient.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), manufacturing instructions, the instructions for use (ifu), and quality control data.One hiwire nitinol hydrophilic wire guide was returned for investigation.The device was returned in an open package with the label, confirming the lot number.Under magnification, it appeared the coating on the wire guide has been scraped the wire guide is assembled and packaged by a cook supplier who completed an investigation as well as cook.The supplier and cook reviewed their device history records (dhr) and found no related anomalies.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.A review of manufacturing procedures by the supplier found controls to be in place to assure device integrity prior to shipment.The evidence from the complaint file, device history record, complaint history and manufacturing documents indicates that the complaint device was manufactured to specification as well as other items in the lot or similar devices in the field or in house.Supplier investigation the supplier carried out an analysis of the returned product and noted the following the specimen presented skive/cut damage in a proximal to distal orientation located 64.8 to 64.9cm from the distal tip, exposing the metallic core wire.The specimen also presented multiple, multi-directional kinks/bends of varying severity and frequency scattered from 6.10 to 130.5cm from the distal tip.The supplier noted the nature of the skive/cut damage to the polymer jacket material appeared consistent with manipulation of the device within a metal cannula or needle and the nature of the bend damage appeared consistent with manipulation of the device against resistance.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions · manipulation of wire guide requires appropriate imaging control.Use caution not to force or over manipulate the wire guides when gaining access.· when using wire guide through a metal cannula/needle, use caution as damage may occur to outer coating.Based on the returned device, it appears handling and/or device interface factors have contributed to the event.However, the customer reported finding the damage when they opened the package.Therefore, cook has concluded a cause cannot 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.
Event or Problem Description
Information was available but inadvertently omitted from the previous medwatch report: a new device was used to complete the procedure.

• 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: 13904986
• Report Number: 1820334-2022-00461
• Device Sequence Number: 4065849
• Product Code: OCY
• UDI-Device Identifier: 00827002304758
• UDI-Public: (01)00827002304758(17)240404(10)71001590
• 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,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2022

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 Expiration Date: 04/04/2024
• Device Model Number: G30475
• Device Catalogue Number: HWAS-035150
• Device Lot Number: 71001590
• 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: 03/11/2022
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2021
• 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