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

Model Number	N/A
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/19/2017
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 customer reported that the universa soft ureteral stent set was found damaged when tested prior to performing an unspecified procedure.The damage was not described further.The device did not come in contact with the patient.The customer opened a new set of universa soft ureteral stent to complete the procedure.Additional information requested from the customer.
Additional Manufacturer Narrative
Investigation summary: a review of the complaint history, device history record, specifications, documentation, drawing, and a visual inspection of the returned device were conducted during the investigation.One used stent, catalog number ush-624-r, was received; positioner was also returned.Tether was not returned with the stent.Proximal coil is torn from the last sideport through the end of the stent coil.The horizontal rip gapped open 1mm.Point of separation has a jagged edge.Distance between last sideport and point of separation is 3mm on one side and 5mm on the opposite side of the torn area.5mm minimum is the required distance of this measurement.This indicates a small piece of material is missing from one side of the coil and was not returned.Width of the proximal coil measured 19mm, specification requirement for coil width is 15-18mm, this coil has been elongated and stretched out of tolerance.Coil was torn during tether removal.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.It is possible to suggest the damage occurred due to the device being mishandled by the user.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.The quality engineering risk assessment for this failure mode was reviewed and it was determined that no additional risk mitigating activity is required at this time.The appropriate personnel will be 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: 6716937
• Report Number: 1820334-2017-01714
• Device Sequence Number: 1761326
• Product Code: FAD
• UDI-Device Identifier: 10827002499734
• UDI-Public: (01)10827002499734(17)191228(10)NS7550020
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K151051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2018

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: N/A
• Device Catalogue Number: USH-624-R
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/19/2017
• Supplement Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 07/17/2017
• Supplement Report FDA Received Date: 01/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1