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

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 physician removed the broken piece of universa soft ureteral stent set from the patient using a stent grasper.No unintended section of the device remained inside the patient¿s body.The patient did not require any additional procedures due to this occurrence but it extended the operating room and anesthesia time for the patient by few minutes.There were no adverse effects to the patient.
Additional Manufacturer Narrative
Date received by manufacturer has been corrected.The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, functional test, manufacturing instructions and visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device reported: physical examination: one open package was received.Sent without the tether and positioner were returned.Positioner was lodged 3 mm inside the stent.Proximal coil was torn 1.2 cm from proximal end of stent, tear measures 6 mm in length and started at the first side-port.Outside diameter of positioner at the distal tip measures.066".Inside diameter of the stent at the distal tip measured.043" the end that has been stretched out inside diameter measured.052".Both components measured within specification.The complaint device was returned therefore, an investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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: 6449681
• Report Number: 1820334-2017-00527
• Device Sequence Number: 19176927
• Product Code: FAD
• UDI-Device Identifier: 00827002536876
• UDI-Public: (01)00827002536876(17)191207(10)7497893
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: US-500
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/07/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/31/2017
• Supplement Report FDA Received Date: 04/05/2017; 05/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention