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

Model Number	G23415
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, two universa firm ureteral stent set were placed in the patient (one in the right and one in the left ureter) during an unknown procedure for an unknown amount of time.The tethers from both stents separated from the stents when the patient attempted removal of the stents from home.The patient returned to the hospital to have both stents removed.This report is for the stent associated with lot number 15054830.Reference patient identifier (b)(6) for the stent associated with lot number 15069537.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information has been requested but is not available at this time.
Additional Manufacturer Narrative
Postal code: (b)(6).Annex code g = g0405215 - suture thread.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 or Problem Description
Additional information was received 22mar2023: the stent was in place a " few weeks." the stent was not encrusted.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Summary of event: it was reported, two universa firm ureteral stent set were placed in the patient (one in the right and one in the left ureter) during an unknown procedure for an unknown amount of time.The tethers from both stents separated from the stents when the patient attempted removal of the stents from home.The patient returned to the hospital to have both stents removed.This report is for the stent associated with lot number 15054830.Reference patient identifier 390639 (mdr # 1820334-2023-00285) for the stent associated with lot number 15069537.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information was received 22mar2023: the stent was in place a "few weeks." the stent was not encrusted.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control (qc) procedures were conducted during the investigation.Interviews of personnel were also conducted during the investigation.The complaint device was not returned to cook for investigation.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.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.The product ifu cautions ¿the tether should be removed if the stent is to remain indwelling longer than 14 days.¿ the information provided upon review of complaint file, device history record, complaint history, and quality control documents provides evidence to support that the device was manufactured to specification.The complaint reported by the customer of the stent¿s tether becoming separated from the stent was confirmed via customer testimony.Based upon the available information and results of the investigation, cook has concluded that the exact cause for the separation could not be established.However, based on the details received by the customer, it appears that the precaution of ¿the tether should be removed if the stent is to remain indwelling longer than 14 days¿ that is stated in the ifu, may not have been followed.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: UNIVERSA FIRM 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: 16588549
• Report Number: 1820334-2023-00284
• Device Sequence Number: 20307196
• Product Code: FAD
• UDI-Device Identifier: 10827002234151
• UDI-Public: (01)10827002234151(17)251104(10)15054830
• Combination Product (Y/N): N
• PMA/510(K) Number: K161236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/04/2025
• Device Model Number: G23415
• Device Catalogue Number: UFH-724-RT1
• Device Lot Number: 15054830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/08/2023
• Supplement Date Received by Manufacturer: 03/22/2023; 06/19/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 04/04/2023; 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2022
• 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
• Patient Sex: Unknown