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

Model Number	G18155
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, parts of the coating of a roadrunner the firm hydrophilic wire guide separated from the device.No portion of the device was left in the patient.There were no additional procedures or prolonged hospitalization.No adverse effects to the patient occurred due to this event.Additional event information has been requested.
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
Additional information was received on 04jan2022: the coating was separated when the guide wire was inserted into the cystoscope.This same malfunction occurred with two devices during the same procedure.
Additional Manufacturer Narrative
Event summary: as reported, parts of the coating of a roadrunner the firm hydrophilic wire guide separated from the device.The coating was separated when the guide wire was inserted into the cystoscope.This same malfunction occurred with two devices during the same procedure.No portion of the device was left in the patient.There were no additional procedures or prolonged hospitalization.No adverse effects to the patient occurred due to this event.Investigation - evaluation: a document-based investigation was performed including a review of complaint history, device history record (dhr), manufacturing instructions, and quality control data.It was reported that the user facility would not be returning the complaint device.A picture was provided that shows the distal tip separated.It appears in the photo that a section of the polymer jacket has separated as well as a portion of the metal part of the wire guide.A review of the device history record found no non-conformances related to the reported failure mode.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 related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The wire guide is not supplied with an ifu.Cook has concluded a cause for the complaint cannot be established.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database 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
• 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 ; 8128294891
• MDR Report Key: 13151330
• Report Number: 1820334-2022-00007
• Device Sequence Number: 14822611
• Product Code: OCY
• UDI-Device Identifier: 00827002181557
• UDI-Public: (01)00827002181557(17)240924(10)NS14209132
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2022

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: 09/24/2024
• Device Model Number: G18155
• Device Catalogue Number: RPC-038145-0
• Device Lot Number: NS14209132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/21/2021
• Supplement Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2021
• 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