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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Internal Organ Perforation (1987)

Event Type  Injury  

Manufacturer Narrative

Date of event: 2018.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It is reported that the universa soft stent (across multiple sizes) is "way too rigid and has been tearing small contracted bladders." the customer was unable to provide specific details regarding number of cases, dates or specific patient information, but did report "this occurred across the hospital in 2018 with multiple surgeons.The physician stated "these patients have not urinated in years causing bladder atrophy.They have fragile and small contracted (difficult) bladders." the physician also stated that the patients' anatomy post-transplant (kidney) may have caused or contributed to the issue.No section of the device remained inside the patients' body.The patients did not require any additional procedures due to this occurrence.No additional consequences to the patient have been reported.Additional information was requested.No additional specific patient or event information is available.

Event Description

There is no new patient or event information to report.

Manufacturer Narrative

Investigation ¿ evaluation: the complaint device was not returned, therefore visual examination and functional testing could not be performed.A document based investigation was performed including a review of specifications and quality control data.Cook could not complete a review of the device history record (dhr) due to lack of lot information from the user facility.Cook could not complete a search of other complaints associated with the complaint device lot number due to lack of lot information from the user facility.Cook reviewed product labeling.The ifu contains the following precautions and potential adverse events related to the stent perforates bladder failure mode: the precautions include: do not force components during removal or replacement.Carefully remove the components if any resistance is encountered.Individual variations of interaction between stents and the urinary system are unpredictable.Use of the device should be based upon consideration of risk-benefit factors as they apply to your patient.Potential adverse events: complications of ureteral stent placement are documented.These complications include, but are not limited to: extravasations, occlusion, migration, hemorrhage, sepsis, perforation of the urinary tract, peritonitis, encrustation, urinary tract infection, and loss of renal function.Conclusion: it was determined the cause for the issue was related to the reported patent condition of "these patients have not urinated in years causing bladder atrophy.They have fragile and small contracted (difficult) bladders." the reported condition of the patients bladders is likely the cause of the reported issue of tearing bladders.The risk analysis was conducted and concluded no additional risk reduction was required.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.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.

• Brand Name: UNIVERSA SOFT URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8599433
• MDR Text Key: 144697478
• Report Number: 1820334-2019-01115
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K151051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/10/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/25/2019
• Initial Date FDA Received: 05/10/2019
• Supplement Dates Manufacturer Received: 06/21/2019
• Supplement Dates FDA Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other