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

Model Number G49942

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2017

Event Type  malfunction  

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 Description

The user facility reported after a ureteroscopic lithotripsy procedure, upon opening the package, the nurse found a crack at the end of the universa soft ureteral stent.Another device was used in order to complete the procedure.No unintended portion of the device remained inside the patient¿s body.No additional procedures were required due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

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 open package (rpn ush-626, label lot number 8026823) was received; stent only was returned.The tether was not returned with the stent.The proximal stent coil was torn starting at the first side port continuing through the end of the coil.The stent is a component (uss-626-aq) for set ush-626.There is no evidence of manufacturing anomalies observed with the device.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.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 the device history record showed there were three non-conformances found.Two items were found with labels, incorrectly applied and these items were scrapped.One item was noted with a packaging tear/hole/crack/flaw.This item was reworked.A review of complaint history revealed this is the only complaint that has been received that is associated with the complaint device lot number.The evidence presented by the sample and the information provided by the supporting documentation, it appears to indicate procedural and clinical factors have impacted this event.Based on the provided information the definitive root cause is related to product use/handling.The product received excessive pressure.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
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7132746
• MDR Text Key: 95928321
• Report Number: 1820334-2017-04331
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002499423
• UDI-Public: (01)00827002499423(17)200628(10)8026823
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K151051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/09/2018

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
• Device Operator: No Information
• Device Model Number: G49942
• Device Catalogue Number: USH-626
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 02/19/2018
• Supplement Dates FDA Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1