MAUDE Adverse Event Report: BOSTON SCIENTIFIC STENT URET POLARIS 6X28CM; STENT, URETERAL

Catalog Number M0061921340

Device Problem Output Problem (3005)

Patient Problem Bacterial Infection (1735)

Event Date 07/01/2021

Event Type  malfunction  

Event Description

The patient called to report a post op infection with a highly rare bacteria detected in his urine.The concern, although it cannot be confirmed with certainty, is that the implanted stent may be an underlying contributing factor.Per management the concern should be reported as a potential concern for the device, and to see if other facilities have reported any issues related to the stents.

• Brand Name: STENT URET POLARIS 6X28CM
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12266308
• MDR Text Key: 264717279
• Report Number: 12266308
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/22/2021

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: M0061921340
• Device Lot Number: 27087093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24455 DA
• Patient Weight: 83