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

Model Number	N/A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/11/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported after placement of the ureteral stent the device was sucked up into the ureteral orifice.A section of the device did not remain inside the patient¿s body.A ureteroscopy was performed, and a stone basket was used to grab the stent to remove it.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation.One used universa firm ureteral stent was received for evaluation.Only the 5fr 26 cm stent was received.The stent tether and positioner were not returned.The length of the stent measured 25.2 cm.The width of the coils measured 15 mm.No manufacturing anomalies were observed on the stent.The stent was dimensionally within specification.The stent was wired using a.038 stainless wire guide and no occlusions were found.Evaluation of the returned device did not reveal any damage,or non-conformances that would have caused the reported issue.Based on the available information a definitive root cause could not be established.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.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.A review of the device history record showed there were no non-conformances identified during the manufacturing process that would have caused or contributed to the reported product issue.A review of complaint history for this product/lot number combination revealed this is the only complaint that has been received against lot # 7226003.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: 6156076
• Report Number: 1820334-2016-01472
• Device Sequence Number: 89397
• Product Code: FAD
• UDI-Device Identifier: 10827002233987
• UDI-Public: (01)10827002233987(17)190825(10)7226003
• 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
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2017

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-526-RT1
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/11/2016
• Supplement Date Received by Manufacturer: 08/29/2017
• Initial Report FDA Received Date: 12/08/2016
• Supplement Report FDA Received Date: 08/31/2017
• 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