MAUDE Adverse Event Report: COOK INC C-FLEX DOUBLE PIGTAIL URETERAL STENT SET; FAD STENT, URETERAL

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported by the user facility that a patient underwent an unknown procedure using an c-flex double pigtail ureteral stent set.The attending physician indicated that while inserting the stent a piece of plastic sheared off the sheath.No unintended sections of the device remain inside the patient¿s body nor did the patient experience any additional procedures or adverse effects due to this occurrence.No further information was provided.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, specifications, quality control and visual inspection of the returned device was conducted during the investigation.The customer returned a spiral shaped piece of stent material for evaluation.The sliver of material was verified as material from the catheter.Review of the failure evaluation indicates the sliver has a shape that is consistent with damage caused by contact with a sharp edge.There is no evidence that this happened prior to opening the package and use at the facility.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 provided information a definitive root cause cannot be established at this time.However, it is possible that the stent may have been scraped on an instrument of undetermined origin.We will continue to monitor for similar complaints.

• Brand Name: C-FLEX DOUBLE PIGTAIL URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6303213
• Report Number: 1820334-2017-00175
• Device Sequence Number: 18907867
• Product Code: FAD
• UDI-Device Identifier: 00827002147874
• UDI-Public: (01)00827002147874(17)181201(10)6418854
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 036316
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/01/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2017
• Supplement Report FDA Received Date: 06/21/2017
• 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