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

Model Number	G49945
Medical Device Problem Code	Split (2537)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The area representative reported during insertion of the universa soft ureteral stent, upon passing the stent over wire, a split in the distal end of the stent was noticed.The stent was removed and another stent opened and used without incident.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation summary: a review of the complaint history, instructions for use(ifu), device history record, specifications and a visual inspection of the returned device were conducted during the investigation.One open package was received; positioner, pigtail straightener and stent were returned.The tether was not returned with the stent.Proximal end of the stent was torn starting at the first sideport and stopped 4mm from the end of the coil.Under magnification striations, with material fibers was observed on the torn edge.There was no evidence of manufacturing anomalies observed with the device.Additionally, a document based investigation evaluation was performed.There was no evidence to suggest the product was not made to specifications.A review of the device history record found no non-conformances associated with the complaint device lot number.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause cannot be determined at this time; however, it is possible the damage occurred due to excessive pressure being placed on the stent.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed 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: 7022973
• Report Number: 1820334-2017-03922
• Device Sequence Number: 18863595
• Product Code: FAD
• UDI-Device Identifier: 00827002499454
• UDI-Public: (01)00827002499454(17)200707(10)8047027
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2018

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 Model Number: G49945
• Device Catalogue Number: USH-600
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/17/2017
• Supplement Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 11/10/2017
• Supplement Report FDA Received Date: 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1