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

Model Number	N/A
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported during a ureteroscopy procedure upon removing the tether, the stent ripped.The stent was left within the patient, as intended.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation / evaluation correction from serious injury to malfunction report.Product has not been received and the investigation is ongoing.A follow up report will be sent upon completion of the investigation.
Event or Problem Description
It was reported during a ureteroscopy procedure, upon removing the tether, the stent ripped.The stent was left within the patient, as intended.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, specifications and quality control was conducted during the investigation.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.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, it is feasible to suggest that the user exerted excessive force when removing the tether from the patient, a definitive root cause cannot be established or reported at this time.The appropriate internal personnel have been notified.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: UNIVERSA SOFT URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5856017
• Report Number: 1820334-2016-00726
• Device Sequence Number: 370089
• Product Code: FAD
• UDI-Device Identifier: 10827002537009
• UDI-Public: (01)10827002537009(17)190408(10)6877204
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 07/12/2016

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: US-626-R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/12/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/09/2016
• Supplement Report FDA Received Date: 11/08/2016; 01/18/2017
• Patient Sequence Number: 1