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

Catalog Number UFH-626

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 05/17/2019

Event Type  Injury  

Manufacturer Narrative

Pma/510(k): k161236.(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

As reported, a universa firm ureteral stent set was difficult to remove from a 55 year-old male patient with a history of right kidney stones, right kidney "seeper", and right ureteral stenosis.The right ureteral stent was removed laparoscopically under general anesthesia.The patient is reportedly "well" after stent removal.There has been no report that any part of the device remained in the patient's body or that the patient experienced any adverse effects due to this event.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Additional information: b5 h6.Corrected information: b1, h1, h6 (patient code and device code).B1: there was no adverse event or reportable product malfunction h1: there was no serious injury to the patient.Clarified information revealed that the patient did not require percutaneous removal of the device.H6: device code: appropriate code not available: there was no adverse event.There was no reportable device malfunction.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 documentation, drawing, manufacturing instructions, instructions for use (ifu), and quality control data.A review of the device history record (dhr) was not conducted due to lack of lot information from the user facility.A search for other complaints associated with the complaint device lot could not be completed due to lack of lot information from the user facility.The instructions for use (ifu), provides the following information to the user related to the reported issue: cautions "a pregnant patient must be more closely monitored for possible stent encrustation due to calcium supplement."."individual variations of interaction between stents and the urinary system are unpredictable"."periodic evaluation via cystoscopic, radiographic, or ultrasonic means is suggested.The stent must be replaced if encrustation hampers drainage.".A document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Conclusion: the conclusion of the complaint is the cause is a known inherent risk of the device.The complaint was confirmed on the customer¿s testimony as the device was not returned.The review of production processes and quality inspection documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.This failure mode is not considered likely to cause serious injury or death.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.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

Additional information reported: the stent was removed transurethrally with a ureteroscope under general anesthesia, not laparoscopically as originally reported.The device will not be returned, it was discarded by the customer.

• Brand Name: UNIVERSA FIRM URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8700708
• MDR Text Key: 148062571
• Report Number: 1820334-2019-01453
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

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: UFH-626
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/29/2019
• Initial Date FDA Received: 06/14/2019
• Supplement Dates Manufacturer Received: 06/17/2019
• Supplement Dates FDA Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR