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

Model Number	G49941
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 placement of a universal soft ureteral stent set the included guide wire became stuck within the stent.The guidewire was being slid over the stent when teflon from the guidewire was removed, which resulted in the guidewire becoming stuck in the stent.This prevented the stent from being placed.The stent and guidewire were then removed and the case was completed using another same stent set.It was reported that the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
No new patient or event information since the last report was submitted.
Additional Manufacturer Narrative
Investigation - evaluation.It was reported that during placement of a universa soft ureteral stent set (part number ush-624) the coating came off the wire guide and the positioner was stuck in the stent.The components all came from the set and the placement was being carried out using a ureteroscope, another stent was used to complete the procedure.A document-based investigation was performed including a review of complaint history, device history record, quality control data, and the instructions for use (ifu).The complaint device was not returned; therefore, no physical examinations could be performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.A complaint device was not returned and no stock of complaint device lot remained at the north america distribution center so a sample from the same lot could not be inspected.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: -angulation of the wire guide or stent should be avoided.Use of a 0-degree scope lens is recommended.Scopes larger than 21.0 french are suggested.A complaint device was not returned, a review of the device history record was carried out and no related non conformances were identified.Controls were found to be in place for the stent component, wire guide and positioner.Based on the available information its not possible to establish how the teflon became removed from the wire guide or how that contributed to the positioner becoming stuck in the stent.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.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 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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: 9646522
• Report Number: 1820334-2020-00239
• Device Sequence Number: 2800704
• Product Code: FAD
• UDI-Device Identifier: 00827002499416
• UDI-Public: (01)00827002499416(17)211026(10)9265072
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K151051
• 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

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: No Information
• Device Expiration Date: 10/26/2021
• Device Model Number: G49941
• Device Catalogue Number: USH-624
• Device Lot Number: 9265072
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR