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

Model Number	G49941
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported, upon opening two universa soft ureteral stent sets, cracks were seen on the pigtail part of the stents.Issue was discovered prior to patient contact.They replaced cracked stents with new product.No adverse events have been reported as a result of the alleged malfunction.
Event or Problem Description
There has been no new information received since the last report was submitted.
Additional Manufacturer Narrative
Additional information: device available for evaluation? investigation ¿ evaluation: a visual inspection of the returned devices was conducted.A document based investigation was also performed including a review of complaint history, the device history record, instructions for use, and quality control data.Two opened universa outer cartons labeled rpn ush-624 with lot number 8256994 were received.A stent was returned in each carton.Stent a- was returned without the tether.There is a tear in the proximal coil starting at the first sideport and continues through the end of the coil.Stent b- was returned without the tether.The stent is partially separated in a circumferential direction around the base of the proximal coil.Stents are inspected to assure tethers are not tangled around the stent.Packaging processes require to assure tethers are not tangled around stent or in the pouch seal.The device history record review showed there were no non-conformances associated with the reported failure.A search of complaint records revealed this is the only complaint for the tether breaking associated with lot number 8256994.A review of manufacturing documents identified this product is inspected before shipment.Two stents were returned, both stents were returned without a tether attached that the product is manufactured with.The tether is attached the to the side port that is closest to the proximal end of the device.One stent has a tear in the proximal coil starting at the first sideport.The other stent has separated in a circumferential direction around the base of the proximal coil.The possible cause of the complaint; the stents were damaged when the tether was removed.A quality engineer risk assessment concluded no risk reduction activities are required.The appropriate internal personnel have been notified and we will continue to monitor 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: 7841861
• Report Number: 1820334-2018-02701
• Device Sequence Number: 11097376
• Product Code: FAD
• UDI-Device Identifier: 00827002499416
• UDI-Public: (01)00827002499416(17)200929(10)8256994
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K151051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2018

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 Expiration Date: 09/29/2020
• Device Model Number: G49941
• Device Catalogue Number: USH-624
• Device Lot Number: 8256994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 09/27/2018
• Patient Sequence Number: 1