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

Model Number	G49933
Medical Device Problem Code	Wrinkled (2614)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/11/2017
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
During an unspecified procedure, the operator detected that the catheter of universa soft ureteral stent set was wrinkled.The operator removed the stent set from the patient¿s body.At this time it is unknown how the intended procedure was completed.Additional information was requested.No unintended section of the device remained inside the patient¿s body.The patient did not require an additional procedure due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
The device was not returned to the manufacturer for evaluation.No photos have been provided.If device becomes available complaint will be reopened and the record will be updated at that time.There is no evidence that a design or process related failure mode contributed to this event.Based on the investigation evaluation, 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.Based on the information provided, a definitive root cause cannot be reported or established at this time.The complaint was confirmed based on the customer¿s testimony.Although a definitive root cause cannot be determined.We will notify the appropriate personnel and continue to monitor for similar complaints.A trackwise search revealed this complaint to be the only one associated with complaint lot number a 7219134.

• 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: 6829605
• Report Number: 1820334-2017-02688
• Device Sequence Number: 818776
• Product Code: FAD
• UDI-Device Identifier: 00827002499331
• UDI-Public: (01)00827002499331(17)190823(10)7219134
• Combination Product (Y/N): N
• PMA/510(K) Number: K151051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2018

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: G49933
• Device Catalogue Number: USH-524
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/14/2017
• Supplement Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 08/30/2017
• Supplement Report FDA Received Date: 03/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1