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

Model Number	N/A
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/29/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that during the diagnostic ureteroscopy procedure, when the physician was about to remove the threads, a universa soft ureteral stent set was found separated prior to use.The device did not come in contact with the patient.There was no patient harm reported and no additional procedures were required because of this failure.It is unknown if the intended procedure was completed or not.Additional information was requested regarding the failure of the device.No additional information has been provided at this time.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, the device history record, instructions for use (ifu), specifications, and a visual inspection of the returned device was conducted.The complaint was confirmed.One universa soft ureteral stent set box labeled (rpn ush-524, lot 6207102) was received.The guide wire was in an unopened package.The positioner and the stent were returned.The pigtail straightener and tether were not returned.The stent was separated 7.5 cm from the edge of the proximal coil, the distal segment measured 16 cm from the edge of the coil.The segments had mating fractures indicating no missing pieces.Under magnification striations were observed on the edge of each segment.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.A review of complaint history for this product/lot number combination revealed this is the only complaint that has been received against this complaint device lot number.Based on the available information and returned device investigation results, the root cause of the event was product use or handling related as the tether was wrapped around the stent and cut through the material during removal.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 SOFT URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6568474
• Report Number: 1820334-2017-01052
• Device Sequence Number: 10916630
• Product Code: FAD
• UDI-Device Identifier: 00827002499331
• UDI-Public: (01)00827002499331(17)180915(10)6207102
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2017

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-524
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/27/2017
• Supplement Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 05/16/2017
• Supplement Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1