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

Model Number	G49913
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510k #: k161236.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was observed prior to opening the package for a universa firm ureteral stent set, that the product was damaged.It was observed that the stent had a "slit around the j curl".Another similar device was used to completed the procedure.No adverse events have been reported as a result of the alleged malfunction.
Event or Problem Description
Additional patient or event information has not been received since the last report was submitted on 03sep2019.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of device history record, the instructions for use, manufacturing instructions, quality control data, and specifications.The complainant returned one opened package containing a universa firm stent for investigation.The returned packaging confirms the reported complaint device lot number.Inspection of the returned device confirmed the stent and positioner, only, were received.The tether of the stent was missing.The proximal coil was torn starting at the first sideport.A review of the device history record found no non-conformances related to the reported failure mode.As 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 have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.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.The stent was returned torn in same location as the tether was originally attached.The stent was returned without a tether.The complaint was confirmed based on customer testimony and analysis of the returned device.Cook has not established the cause of the complaint.It is possible the technique used to remove the tether contributed to the complaint.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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: 8957025
• Report Number: 1820334-2019-02189
• Device Sequence Number: 2151690
• Product Code: FAD
• UDI-Device Identifier: 10827002499130
• UDI-Public: (01)10827002499130(17)220218(10)9529427
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2019

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: 02/18/2022
• Device Model Number: G49913
• Device Catalogue Number: UFH-724-R
• Device Lot Number: 9529427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Initial Date Received by Manufacturer: 08/22/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 10/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1