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

Model Number G46138

Device Problems Material Separation (1562); Difficult to Advance (2920); Inadequate Lubrication (4057)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2022

Event Type  malfunction  

Event Description

It was reported that the coating in the middle of a biwire nitinol hydrophilic wire guide was not smooth.The wire guide holder flushed with saline prior to removing the wire guide from the holder.The user detected the coating in the middle of the wire guide was not smooth while advancing the wire guide.The user noted resistance during attempted advancement and placement.According to the initial reporter, the patient did not experience any adverse effects or additional procedures due to this occurrence.No part of the wire guide separated completely.Additional information was received on 07feb2023 noting that there was skive/cut damage near the distal aspect of the wire, exposing the metallic core wire with missing black polymer jacket material.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Initial reporter phone: (b)(6).Initial reporter occupation unknown.Summary of event: it was reported that the coating in the middle of a biwire nitinol hydrophilic wire guide was not smooth.The wire guide holder flushed with saline prior to removing the wire guide from the holder.The user detected the coating in the middle of the wire guide was not smooth while advancing the wire guide.The user noted resistance during attempted advancement and placement.According to the initial reporter, the patient did not experience any adverse effects or additional procedures due to this occurrence.No part of the wire guide separated completely.Additional information was received on 07feb2023 noting that there was skive/cut damage near the distal aspect of the wire, exposing the metallic core wire with missing black polymer jacket material.Investigation evaluation: a document-based investigation evaluation was performed.Reviews of complaint history, device history record, instructions for use (ifu), and quality control (qc) procedures were conducted during the investigation; document review did not indicate that the device was manufactured out of specifications and does not suggest items in the lot or similar devices in the field or in house are nonconforming.A complaint history database search found no other complaints reported for lot 71002690.A review of the device history record was reviewed and found no related nonconformance's.A review of manufacturing procedures by the supplier found controls to be in place, the wire guides are inspected for defects for the entire length of each wire guide.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 there is no evidence that nonconforming product exists in house or in field.Visual inspection of the returned complaint devices was also conducted.One used device was returned for investigation.Upon inspection there was a rough portion of the wire guide in approximately the middle of the wire guide.Based upon the available information and results of the investigation, 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.

• Brand Name: BIWIRE NITINOL HYDROPHILIC WIRE GUIDE
• Type of Device: 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: 16432621
• MDR Text Key: 310177353
• Report Number: 1820334-2023-00184
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002461383
• UDI-Public: (01)00827002461383(17)250327(10)71002690
• Combination Product (y/n): N
• PMA/PMN Number: K082536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2023

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
• Device Operator: Health Professional
• Device Model Number: G46138
• Device Catalogue Number: BWS-035150
• Device Lot Number: 71002690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2023
• Initial Date Manufacturer Received: 02/07/2023
• Initial Date FDA Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1