MAUDE Adverse Event Report: COOK INC UNIVERSA FIRM URETERAL STENT SET; FAD STENT, URETERAL

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that a teether broke off during an unknown procedure.The physician was able to retrieve and remove the broken part.We were advised that the stent was still able to be deployed.
Additional Manufacturer Narrative
Investigation - evaluation - the complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.A review of the complaint history, device history record, manufacturing instructions and quality control was conducted during the investigation.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, no product returned and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
It was reported that a teether broke off during an unknown procedure.The physician was able to retrieve and remove the broken part.We were advised that the stent was still able to be deployed.

• Brand Name: UNIVERSA FIRM URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5849797
• Report Number: 1820334-2016-00723
• Device Sequence Number: 796785
• Product Code: FAD
• UDI-Device Identifier: 10827002234069
• UDI-Public: (01)10827002234069(17)170716(10)5134915
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K961446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2016

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: UFH-626-RT1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2016
• Supplement Report FDA Received Date: 10/19/2016
• 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