MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CONTOUR POLARIS URETERAL STENT; STENT, URETERAL

Device Problem Calcified (1077)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 01/08/2023

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to report the upn and lot number; therefore, the manufacture date and expiration date are unknown.(b)(4).

Event Description

It was reported to boston scientific corporation that a polaris ultra ureteral stent was placed during an unknown procedure performed on an unknown date.After the procedure, on (b)(6) 2023, the patient experienced an infection that resulted in hospitalization.It was also reported "the patient took one month with the stent and had a lot of pain".The patient symptoms resolved after an unplanned stent removal, performed under sedation.A photo of the complaint device was provided and showed that the stent was calcified.

• Brand Name: CONTOUR POLARIS URETERAL STENT
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16529517
• MDR Text Key: 311205551
• Report Number: 3005099803-2023-01166
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: CS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2023

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2023
• Initial Date FDA Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male