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

Model Number G49898

Device Problem Material Twisted/Bent (2981)

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

Event Date 04/06/2023

Event Type  malfunction  

Event Description

As reported, when the package of a universa firm ureteral stent set was opened.The stent was discovered bent.A new same device was used to complete the procedure.The patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.

Manufacturer Narrative

E1: name and address: (b)(6).H3: device has been returned, and preliminary evaluation has been performed.However, our investigation is ongoing.And device evaluation summary will be included in our follow up report once our investigation has been completed.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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation a representative of (b)(4), informed cook on 12apr2023 of an incident involving an universa firm ureteral stent set (ufh-526-r) from lot 15084445.Reportedly, on 06apr2023, the user opened the package and found the stent to be bent.They changed to another of the same device to complete the procedure.This incident did not result any adverse effects.Reviews of the complaint history, device history record, and quality control procedures, as well as a visual inspection of the device, were conducted during the investigation.One device was returned to cook for evaluation.It was noted that the proximal stent coil was bent and misshapen.A document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for lot 15084445 revealed no recorded non-conformances relevant to the failure mode.A database search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.The information provided upon review of complaint file, device history record, complaint history, and quality control documents did not provide evidence to support that the device was manufactured out of specification or to suggest items in the lot or similar devices in the field or in house were nonconforming.Cook was unable to review the product labeling as the lot was ifu exempt.Based on the information provided, inspection of the returned device, and the results of the investigation, the cause of the bend was not able to be determined.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.¿ per a review of risk documentation, 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

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
• 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: 16877137
• MDR Text Key: 314719571
• Report Number: 1820334-2023-00558
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002498980
• UDI-Public: (01)10827002498980(17)251122(10)15084445
• Combination Product (y/n): N
• PMA/PMN Number: K161236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

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: G49898
• Device Catalogue Number: UFH-526-R
• Device Lot Number: 15084445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/12/2023
• Initial Date FDA Received: 05/05/2023
• Supplement Dates Manufacturer Received: 07/17/2023
• Supplement Dates FDA Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2022
• 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