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

Model Number	G49898
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510k #: k161236.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported, prior to an unspecified procedure using a universa firm ureteral stent set, the package was opened and the stent tip was cracked.The procedure was completed by using another same type device from the same lot.No adverse effects have been reported due to the alleged malfunction.As this occurred prior to patient contact, there was no impact to the patient.
Event or Problem Description
No new patient or event information since the last report was submitted.
Additional Manufacturer Narrative
It was reported the tip of a stent from a universa firm ureteral stent set (part number ufh-526-r) was cracked.This was identified prior to patient contact and the procedure was completed using another new device from the same lot number.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, quality control data, and specifications.One device was returned for investigation.Visual examination confirmed a stent and a positioner were received.Tether and coil straightener were not returned with the stent.The proximal coil on the stent was torn at the first ink band.The tear was isolated around the sideport.Device did not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.A review of the device history record found no non-conformance related to the reported failure mode.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: caution: tether should be removed if stent is to remain indwelling longer than 14 days.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 from the customer has a tear on the proximal coil at the first side port.The tether has been removed from the stent and would have originally been attached at the first side port of the stent on the proximal end.A review of the device history record identified no related anomalies.There have been no other complaint reported for the same lot.Based on the tear location it appears handling and/or procedural factors contributed to the complaint.Cook has concluded that unintended use error likely 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: 9606906
• Report Number: 1820334-2020-00154
• Device Sequence Number: 2739264
• Product Code: FAD
• UDI-Device Identifier: 10827002498980
• UDI-Public: (01)10827002498980(17)220611(10)9803839
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2020

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: 06/11/2022
• Device Model Number: G49898
• Device Catalogue Number: UFH-526-R
• Device Lot Number: 9803839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 01/20/2020
• Supplement Report FDA Received Date: 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1