MAUDE Adverse Event Report: COOK INC UNIVERSA FIRM 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	04/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.
Event or Problem Description
During a ureteroscopy procedure on a male patient, the physician placed the stent.The tether was outside of the patient and as the physician was tying a knot in the tether to shorten it and the tether broke.The physician had to use a piece of the tether that broke off to extend the tether to be outside of the patient.The tether had to be extended because, if the patient were to get an erection, the tether would have been lost inside the patient.The unintended section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects nor required any additional procedures due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), specifications and trends was conducted during the investigation.The device is shipped with an ifu that describes the intended use, specific items are addressed such as: cautions the user not to force components during removal or replacement.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was 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.However, based on the information provided, and no product returned, the root cause is unable to be determined or reported at this time.It is possible that the user exerted too much force while removing the stent.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
During a ureteroscopy procedure on a male patient, the physician placed the stent.The tether was outside of the patient and as the physician was tying a knot in the tether to shorten it and the tether broke.The physician had to use a piece of the tether that broke off to extend the tether to be outside of the patient.The tether had to be extended because, if the patient were to get an erection, the tether would have been lost inside the patient.The unintended section of the device did not remain inside the patient铠body.According to the initial reporter, the patient did not experience any adverse effects nor required any additional procedures due to this occurrence.

• 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: 5633401
• Report Number: 1820334-2016-00295
• Device Sequence Number: 13591754
• Product Code: FAD
• UDI-Device Identifier: 10827002234052
• UDI-Public: (01)10827002234052(17)190211(10)6729395
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 04/15/2016

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UFH-624-RT1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/15/2016
• Device Age: 2 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2016
• Supplement Report FDA Received Date: 10/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1