MAUDE Adverse Event Report: COOK INC STRAIGHT FIXED CORE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/10/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).(b)(4).Event is still under investigation at this time.
Event or Problem Description
During a right ureteroscopy of urinary tract including bladder and ureter on the male patient, the doctor noted that the coating dropped out from the wire when it reached the bladder.The doctor took out the wire immediately and flushed out the specks of the floating coating.No information was provided regarding patient outcome.
Additional Manufacturer Narrative
Evaluation: a review of the following: dimensional verification, review complaint history, review of device history record, review of mi, review of qc, review of specifications, review of trends, visual inspection.A visual inspection of the returned device was conducted during the investigation.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided the root cause could not be determined.Since this device is inspected 100% for bends, kinks, adequate joint strength, correct outside dimension and other surface imperfections prior to transport, it is plausible to suggest that the wire guide encountered resistance possibly by an instrument (ureteroscope) during a procedurally related event, thus causing the removal of the coating.A definitive root cause could not be determined.We will continue to monitor for similar complaints.

• Brand Name: STRAIGHT FIXED CORE WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5956014
• Report Number: 1820334-2016-00954
• Device Sequence Number: 16623439
• Product Code: DXQ
• UDI-Device Identifier: 00827002006706
• UDI-Public: (01)00827002006706(17)210510(10)6912008
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TSF-38-145
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2016
• Supplement Report FDA Received Date: 05/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention