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

Model Number	G53692
Medical Device Problem Codes	Malposition of Device (2616); Difficult to Advance (2920)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a universa soft ureteral stent would not thread over the wire.The stent caught the wire and curled the wire back.After attempting to insert stent, the wire curled back, and the user lost access to ureter.It was reported that the patient had to be admitted overnight for a nephrostomy procedure the following day ((b)(6) 2022) due to this event.Additional information regarding event details, patient anatomy and outcome has been requested but is not available at this time.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Customer occupation = purchasing.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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.
Event or Problem Description
Additional information received 14oct2022: the user attempted to place the stent 3 times on one patient through 3 different approaches; the user also changed the outer sheath size, lubricated the wire, then attempted under fluro.All three attempts were unsuccessful.The user reported that on a separate case, the patient had to undergo a pcnt placement.No unintended section of the device remains inside the patient¿s body.Additional information regarding event details has been requested but is not available at this time.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.B5: additional information received 14oct2022.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Summary of event: it was reported that a universa soft ureteral stent would not thread over the wire.The stent caught the wire and curled the wire back.After attempting to insert stent, the wire curled back, and the user lost access to ureter.It was reported that the patient had to be admitted overnight for a nephrostomy procedure the following day ((b)(6) 2022) due to this event.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), and quality control (qc) procedures were conducted during the investigation; document review did not indicate that the device was manufactured out of specifications and does not suggest items in the lot or similar devices in the field or in house are nonconforming.Visual inspection and a functional tests of the returned complaint devices was also conducted.One, used, universa soft ureteral stent set was returned for investigation.A device failure analysis was conducted on the returned device in which the wire guide was able to pass through the stent without issue.A document-based investigation evaluation was performed.A search of the complaint database [device history record] found no other related complaints or nonconformances reported for lot 14868056.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.Based upon the available information and results of the investigation, cook has concluded that the cause for the complaint could not be established.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering risk assessment, no further action is required.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.
Event or Problem Description
A separate complaint was opened to encompass the three-attempt placement procedure.No additional information regarding this event has been received since the previous medwatch report was sent.

• Brand Name: UNIVERSA SOFT URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 15594680
• Report Number: 1820334-2022-01630
• Device Sequence Number: 2265673
• Product Code: FAD
• UDI-Device Identifier: 00827002536920
• UDI-Public: (01)00827002536920(17)250729(10)14868056
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K151051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/29/2025
• Device Model Number: G53692
• Device Catalogue Number: US-624
• Device Lot Number: 14868056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2022
• Supplement Date Received by Manufacturer: 10/14/2022; 01/10/2023
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 11/08/2022; 01/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown