MAUDE Adverse Event Report: COOK INC SOF-FLEX MULTI-LENGTH 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 Consequences Or Impact To Patient (2199)
Date of Event	04/18/2017
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 tip of sof-flex multi-length ureteral stent set was found broken when the package was opened.The device did not come in contact with the patient.There was no patient harm reported and no additional procedures were required because of this failure.
Additional Manufacturer Narrative
Additional information: 510(k): preamendment investigation ¿ evaluation: a visual inspection of the returned device was conducted.In addition, a review of complaint history, the device history record, instructions for use, and specifications was performed.One open package labeled rpn 039500, lot ns5355663 was received.The stent (mlssf-047032), positioner (stppn-070046-rm) and wire guide (638413) were returned.Stent was returned without the tether.The stent was returned smashed in the tray.Visual examination revealed the proximal coil has been torn starting at the first side port and extended to the middle of the second ink band.The tether has been removed from the stent; excessive pressure applied to the tether during removal has torn the stent coil.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 and device integrity prior to shipping.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 records found no other non-conformances associated with the complaint device lot number.A review of complaint history revealed there have been no other complaints received that have been associated the complaint device lot number.The instructions for use state "upon removal from the package, inspect the product to ensure no damage has occurred." based on the information provided and the results of our investigation, the likely root cause is product use/ handling related.However, a definitive root cause cannot be determined.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: SOF-FLEX MULTI-LENGTH URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6568477
• Report Number: 1820334-2017-01048
• Device Sequence Number: 90425
• Product Code: FAD
• UDI-Device Identifier: 00827002147836
• UDI-Public: (01)00827002147836(17)171013(10)NS5355663
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2018

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: 039500
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/20/2017
• Supplement Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 05/16/2017
• Supplement Report FDA Received Date: 02/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1