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

Model Number G49950

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2022

Event Type  malfunction  

Event Description

As reported, before an ureterorenoscopy procedure, an universa soft ureteral stent set was opened and the user found the front end of the stent was broken.Another device of the same type was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional interventions and did not experience any adverse effects due to this occurrence.

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.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.

Manufacturer Narrative

Summary of event: as reported, before an ureterorenoscopy procedure, an universa soft ureteral stent set was opened, and the user found the front end of the stent was broken.Another device of the same type was used to complete the procedure.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), specification, and quality control procedures were conducted during the investigation.A visual inspection was conducted also.A universa soft ureteral stent was returned to cook for investigation.It was noted that the stent was returned in two pieces with one of the pieces being an entire pigtail.It is not known whether the separated pigtail is the pigtail where the stent tether is located as both ends of this type of stent are tapered.The tether was not returned.One of the side ports on the separated pigtail had a tear originating from it; however, this side port wouldn¿t be associated with the tether even if the separated pigtail was from the tethered end.The torn side port is closer to the body portion of the stent than the taper, where the tethered side port is located.A review of complaint history records shows no other related complaints associated with the complaint device lot.A review of the device history record found no non-conformances related to the reported failure mode.The product ifu provides the following information: ¿precautions: the tether should be removed if the stent is to remain indwelling longer than 14 days.¿ ¿how supplied: upon removal from package, inspect the product to ensure no damage has occurred.¿ because there were no related non-conformances, adequate inspection activities had been established, there was objective evidence that the dhr was fully executed, and no other known lot related complaints had been received from the field, it is concluded that there is no evidence that nonconforming product exists in house or in the field.A review of relevant manufacturing and quality control documents were conducted.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The risk analysis for this failure mode was reviewed and no additional escalation is required.The appropriate personnel have been notified and cook will continue to monitor for similar events.The complaint reported by the customer of the stent being broke was confirmed due to customer testimony and inspection.Despite receiving the device and performing an inspection, the cause of the break was not able to be determined.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 Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: UNIVERSA SOFT URETERAL STENT SET
• Type of Device: 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: 15997426
• MDR Text Key: 308454592
• Report Number: 1820334-2022-01852
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002499508
• UDI-Public: (01)00827002499508(17)251014(10)NS15020526
• Combination Product (y/n): N
• PMA/PMN Number: K151051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G49950
• Device Catalogue Number: USH-726
• Device Lot Number: NS15020526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male