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

Model Number	G18153
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	08/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
As reported in the voluntary medwatch report received from the user facility, "during ureteroscopy procedure, while removing the cook medical roadrunner hydrophilic pc wire, the protective coating shredded upon removal thru the scope.There is a possibility that the provider came into contact with the edge of the scope during removal.All pieces were removed and no harm to the patient." further patient, device and event details have been requested from the user facility, but have not yet been received at the time of this submission.
Additional Manufacturer Narrative
Event was reported under user facility report mw5071826.The coating shredded in the patient.All of the coating was removed.The doctor felt that this was due to the angle in which the wire was being drawn back through the scope.He looked for any remnants left visually and thoroughly irrigated the bladder.The patient has been discharged.(b)(4).Investigation/evaluation: a document-based investigation has been performed, which included review of complaint history, the device history record, manufacturing instructions, and quality control data.Visual inspection and dimensional verification was also conducted.One used device was returned with biomatter present.The surface of the wire guide appears to have been sloughed or scraped off, leaving a rough and uneven surface.The outer diameter of the wire guide was manufactured to current specifications.There is no indication that a design or process-related failure mode contributed to this event.There are several controls in place ensuring the quality of the supplied a review of the device history record was performed and confirmed that no non-conformances were recorded.A search of complaint history records revealed this complaint to be the only reported complaint associated to the complaint lot number (8066140).The complaint was confirmed.The customer stated that the angle which the wire was withdrawn through the scope may have contributed to the coating shredding off from the wire guide.It is feasible to suggest that the incident was a result of a procedurally-related event rather than a non-conformance of the device.The appearance of the returned device supports this conclusion.The root cause will be trended as product use or handling-related - user technique.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• 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
• MDR Report Key: 6865019
• Report Number: 1820334-2017-02972
• Device Sequence Number: 633492
• Product Code: OCY
• UDI-Device Identifier: 00827002181533
• UDI-Public: (01)00827002181533(17)200714(10)8066140
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K082536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2018

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: G18153
• Device Catalogue Number: RPC-035145-0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/06/2017
• Supplement Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 01/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR