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

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2017
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 the patient visited the hospital for removal of previously implanted universa soft ureteral stent set.During the procedure, the physician noticed that there was a knot in one of the pigtails.The physician removed the stent from the kidney.The physician completed the procedure by replacing the stent with another universa soft ureteral stent set.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
Investigation - evaluation: a review of the complaint history, device history record, instructions for use, trends, visual inspection, specifications and quality control data was conducted during the investigation.One used device was received, however the packaging/ label was not returned.Both coils were covered with encrustation.The pigtail was circular and did not contain a knot.There no creases or indications the distal coil has been knotted.Approximately five(5) cm from the tip of the device, some of the sideports on the distal coil were noted to be clogged with a dried substance and would not wire using a hsf-38-50-qc wire guide.The device was supplied with instructions for use (ifu) booklet which warns formation of knots in multi-length stents may occur and one precaution states "individual variations of interaction between stents and the urinary system are unpredictable." 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.A review of the device history record revealed two (2) non-conformances to be associated with device lot number.These non-conformances are not related to the reported issue.Additionally, a review of complaint history revealed one other complaint (b)(4) to be associated with the device lot number, however this complaint is not related to the reported failure mode.Based on the provided information, inspection of returned product, and the investigation, a definitive root cause cannot be established or reported at this time.Per the quality engineering risk assessment no further action is required.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: 6733834
• Report Number: 1820334-2017-01826
• Device Sequence Number: 821610
• Product Code: FAD
• UDI-Device Identifier: 10827002233161
• UDI-Public: (01)10827002233161(17)200317(10)7757711
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K151051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2017

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: N/A
• Device Catalogue Number: USH-600-RT1
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/26/2017
• Supplement Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 11/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR