MAUDE Adverse Event Report: COOK MEDICAL URETERAL STENT, SURGITEK; STENT, URETERAL

Catalog Number UFH-626-RT1

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/05/2020

Event Type  malfunction  

Event Description

Patient in operating room for left ureteroscopy, stent removal left side, laser lithotripsy left ureter, left ureteral stent placement.Upon attempting to remove previous left ureteral stent, stent ripped and only small portion of stent was able to be removed.Retained portion of the stent encrusted.Laser lithotripsy attempted.New left ureteral stent placed distally to previous retained portion of left ureteral stent.Fda safety report id# (b)(4).

• Brand Name: URETERAL STENT, SURGITEK
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): COOK MEDICAL
• MDR Report Key: 9933089
• MDR Text Key: 186775755
• Report Number: MW5094047
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/02/2020

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 Catalogue Number: UFH-626-RT1
• Device Lot Number: 100471164
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR