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

Model Number G49957

Device Problem Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2017

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

It was reported during a cystoscopy procedure, while the physician utilized a cystoscope to insert through the urethra, he discovered the universa soft ureteral stent tip was split.He proceeded with another stent and completed the procedure successfully.No adverse effects or consequences were reported to the patient due to this occurrence.

Manufacturer Narrative

A review of documentation, manufacturing instructions, specification and quality control data was conducted during the investigation.One open package rpn ush-824 was received.Stent and positioner were returned.Stent was returned without the tether.Proximal coil was torn starting at the first sideport and continued through the end of the stent.A braided tether for repositioning and removal of the device is located on the proximal pigtail of the stent.Tether has been pulled out of the stent causing material to tear.No patient harm was reported.There is no indication that a design or process related failure mode contributed to this event.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.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.Based on the provided information, the root cause will be attributed to the product receiving excessive pressure.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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: 7147303
• MDR Text Key: 96063609
• Report Number: 1820334-2017-04425
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002499577
• UDI-Public: (01)00827002499577(17)200816(10)NS8147319
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2018

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: G49957
• Device Catalogue Number: USH-824
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/27/2017
• Supplement Dates Manufacturer Received: 02/07/2018
• Supplement Dates FDA Received: 03/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1