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

Model Number	N/A
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported by the user facility that after the placement of the stent it was sucked back up into the ureteral orifice and the surgeon spent an hour trying to retrieve the stent.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.A section of the device did not remain inside the patient¿s body.
Additional Manufacturer Narrative
Investigation ¿ evaluation.One used universa firm ureteral stent set was returned for investigation without the package or any identifying information.The tether was not returned with the stent.Physical examination of the returned device revealed that the proximal coil measured 23mm, which is outside the specified 13-18mm.No other out of specification conditions were noted.There is no evidence of the cause of the out of specification proximal coil, or that it¿s out of measure diameter caused the reported issue.The definitive root cause for the reported issue cannot be determined based on the information/evidence provided.A review of the device history records for this set of components revealed no non-conformances during the manufacturing process that would have caused or contributed to the reported issue.A review of complaint history for this product/lot number combination revealed there have been no other complaints received.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 FIRM URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6243230
• Report Number: 1820334-2017-00008
• Device Sequence Number: 10979163
• Product Code: FAD
• UDI-Device Identifier: 10827002234083
• UDI-Public: (01)10827002234083(17)190823(10)7219130
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K961446
• 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): 09/01/2017

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: UFH-630-RT1
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/15/2016
• Supplement Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 01/11/2017
• Supplement Report FDA Received Date: 09/01/2017
• 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