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 06/04/2019

Event Type  Injury  

Manufacturer Narrative

(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 during removal of a universa firm ureteral stent from the right ureter, there was obvious encrustation making it difficult to remove the stent.The physician removed the stent with a laparoscope under general anesthesia "while the patient was in relax." the patient did not experience any adverse effects as a result of this occurrence.No unintended section of the device remained inside the patient's body.Additional details regarding the patient and event have been requested.At this time, no additional information has been provided.

Manufacturer Narrative

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.No reportable device malfunction.This report includes information known at this time.Based on additional information received, there was no serious injury to the patient and no reportable product malfunction, therefore a follow up report will not be submitted.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 received: the device was removed transurethrally through a ureteroscope under general anesthesia, not percutaneously with a laparoscope 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: 8700722
• MDR Text Key: 148062064
• Report Number: 1820334-2019-01442
• 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: distributor,foreign,other,use
• 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: 06/05/2019
• 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: 48 YR