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

Model Number	G49945
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/19/2017
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
It was reported that upon removal from the sterile package, they noticed that a stent from a universa soft ureteral stent set was split.The stent was not used.No patient involvement.
Additional Manufacturer Narrative
Investigation ¿ evaluation: the universa soft ureteral stent was returned without the tether.The proximal end of stent was torn starting at the first side port and up to the edge of the coil.There is no evidence of manufacturing anomalies observed with the device.A review of the device history record revealed three non-conformances for this device lot number.Two items were found to have loose foreign matter and one item was found to have foreign matter embedded in the packaging.All three nonconforming items were reworked.A review of complaint history revealed no additional complaints with the complaint device lot number of 8373193.There is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The root cause is related to product use or handling.The stent was likely torn when removing the tether during the preparation process.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.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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: 7175011
• Report Number: 1820334-2018-00029
• Device Sequence Number: 1979033
• Product Code: FAD
• UDI-Device Identifier: 00827002499454
• UDI-Public: (01)00827002499454(17)201114(10)8373193
• 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): 03/26/2018

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: 12/19/2017
• Supplement Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 01/09/2018
• Supplement Report FDA Received Date: 03/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1