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

Model Number	G49898
Date of Event	08/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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, during an unknown procedure using a universa firm ureteral stent set, the operator opened the pouch and found the pigtail was deformed.The procedure was completed by using a new stent.No adverse effects have been reported due to the alleged malfunction.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event summary: it was reported that a stent from a universa firm ureteral stent set was deformed.The pouch was opened and the pigtail was found to be deformed.The procedure was completed by using a new stent.The stent was reported to be stored in its marketing box.There was no reported adverse effects a as result of the complaint event.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, specifications, and quality control data.Visual examination confirmed the stent only was received.The tether has been removed from the stent and was not returned.The proximal coil was bent backward and had a severe kink 4cm from the end of the coil.The stent did not wire through the kink in the coil using a hsf-035-50qc wire guide.A review of the device history record (dhr) 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 related complaints from the lot 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) provided with this device caution, "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." based on the information available, cook has concluded that a cause for this complaint could not be established.Manufacturing, shipping/handling, or product handling in a clinical setting could not be ruled out as possible causes of the complaint.Per the quality engineering risk assessment, no further action is warranted.Cook medical 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.
Event or Problem Description
No new patient or event information since the last report was submitted.

• 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: 10463830
• Report Number: 1820334-2020-01579
• Device Sequence Number: 11434586
• Product Code: FAD
• UDI-Device Identifier: 10827002498980
• UDI-Public: (01)10827002498980(17)230107(10)10249881
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K161236
• 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): 12/08/2020

1 Device 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: 01/07/2023
• Device Model Number: G49898
• Device Catalogue Number: UFH-526-R
• Device Lot Number: 10249881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No