MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIMA URETERAL STENT SYSTEM; STENT, URETERAL

Catalog Number M001274020

Device Problems Material Too Rigid or Stiff (1544); Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/16/2019

Event Type  malfunction  

Event Description

Ureteral stent system includes a flexible stiffening cannula to use during placement.Cannula would not advance the entire length of the stent.Multiple attempts were made.Unable to use defective device.Fda safety report id# (b)(4).

• Brand Name: FLEXIMA URETERAL STENT SYSTEM
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION ; marlborough MA 01752
• MDR Report Key: 9214088
• MDR Text Key: 163301714
• Report Number: MW5090504
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/17/2019

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 Expiration Date: 12/11/2021
• Device Catalogue Number: M001274020
• Device Lot Number: 23075996
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/18/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1