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

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported by the user facility that the tethered suture stretched and frayed.The physician was able to cut the suture and remove the suture.The new suture was used to restitch the device with no further complications to the patient.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation.A review of the device history record, complaint history, quality controls, specification and visual inspection was conducted on the returned device during the investigation.Incomplete device was returned for investigation.It was discovered that only a tether was returned, which was tangled together.During investigation, the tether was untangled and it was observed that the tether was separated into three segments.Two segments had severely stretched appearances indicating that it was pulled by force stressing the material to the point of snapping to separation.Third segment was noted to have the knot intact.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.In addition review of device master record did not observe any nonconformance that may have contributed to this incident.Based on the provided information a definitive root cause cannot be established or reported at this time.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: 6240305
• Report Number: 1820334-2017-00100
• Device Sequence Number: 755905
• Product Code: FAD
• UDI-Device Identifier: 10827002233772
• UDI-Public: (01)10827002233772(17)190824(10)7222603
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K151051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2017

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-628-RT1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/05/2017
• Supplement Date Received by Manufacturer: 06/20/2017
• Initial Report FDA Received Date: 01/11/2017
• Supplement Report FDA Received Date: 07/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1