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 Consequences Or Impact To Patient (2199)
Date of Event	01/11/2017
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 ureteroscopy using a universa soft ureteral stent set.The attending physician tried to remove the device from the patient when the tether broke.The physician indicated he was not familiar with the tether on this device but he was more familiar with the braided tether.The physician was able to remove the stent but by using a grasper and was able to finish the procedure.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: one universa soft ureteral stent was returned for investigation without any identifying lot or rpn number.Visual inspection noted the tether is severed and pulled out of the stent.The stent is intact and measures 24 in length.Tether severed on one side 30.6 cm from the knot.The total working length approximately 41-43 cm from the knot.Evaluation of the returned device confirmed the reported issue.Monofilament tethers are designed to fail to protect the stent from damage and the patient from harm resulting from excessive stress caused by the tether.A definitive root cause was not able to be determined.A review of the device history records for this product revealed no non-conformances during the manufacturing process.A review of complaint history for this product/lot number combination revealed there have been no other complaints received for lot number 7445524.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.
Additional Manufacturer Narrative
The event is currently under investigation.A final report will be send upon conclusion.

• 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: 6295842
• Report Number: 1820334-2017-00220
• Device Sequence Number: 853051
• Product Code: FAD
• UDI-Device Identifier: 10827002233833
• UDI-Public: (01)10827002233833(17)191115(10)7445524
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K151051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2017

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: USH-726-RT1
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/11/2017
• Supplement Date Received by Manufacturer: 01/11/2017; 09/15/2017
• Initial Report FDA Received Date: 02/02/2017
• Supplement Report FDA Received Date: 09/05/2017; 09/20/2017
• 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