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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.(b)(4).The event is currently under investigation.
Event or Problem Description
A patient with a large obstructing right upj stone underwent stent placement.When placing the stent, the string on the stent kept fraying and eventually broke inside the patient's bladder.The surgeon was able to retrieve the remaining string which added more time in surgery under anesthesia.
Additional Manufacturer Narrative
Investigation ¿ evaluation.The universa soft ureteral stent set was not returned for evaluation.No photographs were provided for review.Without the complaint device, a physical investigation was not able to be performed.Based on the information provided, the actual root cause is unknown and no conclusion can be drawn.There is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the device history record showed there were no non-conformances identified during the manufacturing process that would have caused or contributed to the reported product issue.A review of complaint history for this product/lot number combination revealed one other similar complaint on this lot related to tether breakage.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• 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: 6096635
• Report Number: 1820334-2016-01382
• Device Sequence Number: 695512
• Product Code: FAD
• UDI-Device Identifier: 10827002233741
• UDI-Public: (01)10827002233741(17)180521(10)5902330
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2017

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: No Information
• Device Model Number: N/A
• Device Catalogue Number: USH-624-RT1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/04/2016
• Supplement Date Received by Manufacturer: 09/01/2017
• Initial Report FDA Received Date: 11/11/2016
• Supplement Report FDA Received Date: 09/06/2017
• 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