MAUDE Adverse Event Report: COOK INC ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number G18154

Device Problem Material Deformation (2976)

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

Event Date 10/06/2021

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, a roadrunner the firm hydrophilic wire guide was found to have a slight scratch in the middle of the device on the coating after it was removed from the package.The issue with this device was discovered prior to making contact with the patient and it was not used.A new product was used to complete the unspecified surgery.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.There were no adverse effects on the patient due to this occurrence.

Event Description

Additional information was received (b)(6) 2021: as reported, there were a quantity of two, roadrunner the firm hydrophilic wire guide that were found to have a slight scratch in the middle of the device on the coating after it was removed from the package.Both devices were from the same reported lot and the issue was discovered during the same unspecified procedure.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event description: as reported, two roadrunner the firm hydrophilic wire guides were found to have a slight scratch in the middle of the devices on the coating after they were removed from their packages.The issue with these devices were discovered prior to making contact with the patient and they were not used.A new product was used to complete the unspecified surgery.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.There were no adverse effects on the patient due to this occurrence.Investigation ¿ evaluation.A document based investigation was performed including a review of complaint history, device history record (dhr), and quality control data.The complaint device was not returned; therefore, no physical examinations could be performed.A photo was provided, however it is out of focus and it is not possible to identify the scratch on the photo.A document based investigation evaluation was performed.There is no evidence to suggest this device was manufactured out of specification.A review of the device history record 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 were 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 the field.A review of relevant manufacturing and quality control documents was conducted and controls were found to be in place, the wire guides are visually inspected for damaged and smooth coating.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.As the device was not returned and the damage was not clearly visible in the picture provided it was not possible to establish a cause of the complaint.The risk assessment for this failure mode was reviewed, and it was determined that no actions are 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.

• Brand Name: ROADRUNNER THE FIRM 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: 12668637
• MDR Text Key: 277640345
• Report Number: 1820334-2021-02361
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002181540
• UDI-Public: (01)00827002181540(17)240608(10)NS13974569
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: G18154
• Device Catalogue Number: RPC-035145
• Device Lot Number: NS13974569
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• 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