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

Model Number	G23397
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: other non-healthcare professional: surgical services business manager investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, the instructions for use, manufacturing instructions, quality control data, and specifications.One device was returned for investigation.Visual examination confirmed a stent only was received.The tether and coil straightener are intact on the stent.The proximal coil was bent backward and severely kinked at a sideport.The kink was located 3.7cm from the end of the coil.A wire guide could not be transitioned through the kinked area.The distal coil was uniform and had no damage; the coil was wired using the wire guide.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: cautions: tether should be removed if stent is to remain indwelling longer than 14 days.Do not force components during removal or replacement.Carefully remove the components if any resistance is encountered.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.The returned stent was observed to have a proximal coil that is bent backward and kinked at a sideport.The kink was measure to be 3.7cm from the end of the coil.A wire guide would not transition through the kinked area.The distal coil is uniform and has no damage and would wire without issue.A review of the device history record found no related complaints and there have been no other complaints reported for the same lot.The stents are wire during production and visually inspected in final inspection.It is possible the device was damaged after it was packaged in shipment or in storage.Based on the available evidence a cause for the stent kinking has not been established.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.
Event or Problem Description
It was reported that prior to an unknown procedure, one end of a universa firm ureteral stent was crushed.The stent was not used and another was used to complete the procedure.It was reported the patient did not experience any adverse effects due to this occurrence.

• 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: 10194246
• Report Number: 1820334-2020-01185
• Device Sequence Number: 16370818
• Product Code: FAD
• UDI-Device Identifier: 10827002233970
• UDI-Public: (01)10827002233970(17)230303(10)13024544
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K161236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2020

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 Expiration Date: 03/03/2023
• Device Model Number: G23397
• Device Catalogue Number: UFH-524-RT1
• Device Lot Number: 13024544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 06/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1