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

Model Number	G49937
Medical Device Problem Code	Split (2537)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2017
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 user facility reported while trying to use the universa soft ureteral stent, a split distal end caused it to not be able to be used.As reported, there was no harm to the patient.Additional patient, device and event information has been requested but reply has not been received at the time of this report.
Additional Manufacturer Narrative
Investigation ¿ evaluation: the investigation included a visual inspection of the returned device, a review of complaint history, the device history record, instructions for use (ifu), quality control data, and the device specifications.One universa soft ureteral stent was received in an open package containing, label lot 8003102.Only the stent and wire guide were returned.The wire guide was returned in an unopened pouch.The tether was not returned with the stent.The proximal coil was torn starting at the first side port and continuing through the end of the coil.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-conformance's identified.A review of complaint history for this product/lot number combination revealed this is the only complaint that has been received.Based on the evidence presented by the sample and physical analysis, the stent was torn during tether removal.The root cause was determined to be related to product use and handling.The product received excessive pressure.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: 6864933
• Report Number: 1820334-2017-02874
• Device Sequence Number: 1222023
• Product Code: FAD
• UDI-Device Identifier: 00827002499379
• UDI-Public: (01)00827002499379(17)200620(10)8003102
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 12/19/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: G49937
• Device Catalogue Number: USH-500
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/06/2017
• Supplement Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1