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

Model Number	N/A
Medical Device Problem Code	Split (2537)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/25/2017
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
International customer reported that a patient was scheduled to undergo placement of a universa soft ureteral stent for an unspecified indication.The device was opened and examined prior to use.The staff noticed that the device had a split; the details and location of the split were not provided.The device was removed from the field and a replacement device was obtained.There was no delay in the procedure.There was no patient contact, accordingly there are no reported adverse patient events.The device is not available for evaluation.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.One open package was received; the stent and positioner were only returned.The tether was not returned with the stent.Stent was split on the proximal coil starting at last sideport, the split extended through the end of the coil.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number that is associated with the defect described in this complaint.Based on the information provided, the examination of the returned product, and the results of our investigation, the root cause of this event is product use or handling related as the event occurred when the operator was removing the tether during the prepping process prior to insertion into the patient.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: 6747957
• Report Number: 1820334-2017-01861
• Device Sequence Number: 1018092
• Product Code: FAD
• UDI-Device Identifier: 10827002499697
• UDI-Public: (01)10827002499697(17)200208(10)7659682
• 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: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2017

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: No Information
• Device Model Number: N/A
• Device Catalogue Number: USH-500-R
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/10/2017
• Supplement Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 07/27/2017
• Supplement Report FDA Received Date: 12/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1