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 Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/15/2017
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 prior to performing an ureterorenoscopy, the physician opened a universal soft ureteral stent set and found a fissure in the front end of the stent.The device did not come in contact with the patient.The physician used another stent set to complete the procedure.There was no known patient harm reported due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: the investigation included a visual inspection of the returned device, a review of complaint history, the device history record, instructions for use, quality control data, and the device specifications.One outer carton and open inner pouch labeled rpn ush-626, label lot number 7352801 was received.Only the stent and positioner was returned.The tether was not returned.The proximal end of the stent was torn starting at the last side port continuing through the end of the coil.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 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 record showed there were no non-conformances associated with the complaint device lot number.A review of complaint history revealed this is the only complaint that has been received associated with the complaint device lot number.The complaint was confirmed based on the physical evaluation of the returned product.Based on the provided information the definitive root cause is related to the product receiving excessive pressure.The stent was torn during removal of the tether suture.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.

• 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: 6683814
• Report Number: 1820334-2017-01592
• Device Sequence Number: 46285
• Product Code: FAD
• UDI-Device Identifier: 00827002499423
• UDI-Public: (01)00827002499423(17)191012(10)7352801
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K151051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2018

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: No Information
• Device Model Number: N/A
• Device Catalogue Number: USH-626
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/12/2017
• Supplement Date Received by Manufacturer: 12/20/2017
• Initial Report FDA Received Date: 07/03/2017
• Supplement Report FDA Received Date: 01/09/2018
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 65