MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ASCERTA¿; STENT, URETERAL

Model Number M0061456140

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/26/2022

Event Type  malfunction  

Event Description

Ascerta 6f x 26cm ureteral stent (ref # (b)(4), lot # 29366128, expiration date: 01/31/2024) tore when scrub technician pulled the guidewire out.Stent was originally planned to be an implant in patient's left ureter.Surgeon was aware of the situation and ended removing the stent since it is no longer needed for the procedure.Registered nurse manager was informed of the defective stent.Stent device with box information saved and placed in manager's office.

• Brand Name: ASCERTA¿
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 15462271
• MDR Text Key: 300386662
• Report Number: 15462271
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M0061456140
• Device Lot Number: 29366128
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/06/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/22/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male