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

Model Number G49941

Device Problem Unraveled Material (1664)

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

Event Date 04/10/2023

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.G2 report source: medwatch report # mw5116892.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.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 Description

It was reported, during a stent exchange procedure, the wire guide of the universa soft ureteral stent set unraveled when the physician was removing the wire guide after the stent placement.Fluoroscopy was required to determine no retained pieces of wire remained in patient.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Summary of event: it was reported, during a stent exchange procedure, the wire guide of the universa soft ureteral stent set unraveled when the physician was removing the wire guide after the stent placement.Fluoroscopy was required to determine no retained pieces of wire remained in patient.The wire guide that came with the device set was used for the procedure.No resistance was felt when removing the wire guide.The wire was removed and the user noted that it had unraveled.The stent was placed as intended.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), quality control (qc) procedures, and personnel interviews were conducted during the investigation.A document-based investigation evaluation was performed.A search of the device history record found no related non-conformances reported for lot 14809257.A complaint history database search showed no other related complaints associated with the complaint device lot 14809257.The evidence from the complaint file, device history record, complaint history and quality control documents indicates that the complaint device was manufactured to specification as well as other items in the lot or similar devices in the field or in house.Cook also reviewed product labeling.The ifu (t_usus_rev2; 'universa soft ureteral stents and stent sets') supplied with the device states the following in consideration of the reported failure mode: - "precautions: [.] do not force components during removal or replacement.Carefully remove the components if any resistance is encountered.¿ the complaint device was not returned; therefore, no functional testing or visual inspections could be performed.The device for the complaint was initially logged as ¿unsure¿ if it would be returned.A request to the customer was sent along with additional questions.After four attempts to receive answers from the customer, answers to the additional questions were received but not a response to the product return question.Due to this it was assumed that the device would not be returned.The complaint reported by the customer of the wire guide unraveling was confirmed via customer testimony.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 Description

Additional information received on 03aug2023: the wire guide that came with the device set was used for the procedure.No resistance was felt when removing the wire guide.The wire was removed and the user noted that it had unraveled.The stent was placed as intended.

• 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: 16854688
• MDR Text Key: 314397184
• Report Number: 1820334-2023-00535
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002499416
• UDI-Public: (01)00827002499416(17)250623(10)14809257
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/28/2023

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
• Device Operator: Health Professional
• Device Model Number: G49941
• Device Catalogue Number: USH-624
• Device Lot Number: 14809257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/10/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 08/03/2023
• Supplement Dates FDA Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2022
• 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