• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION CONTOUR POLARIS URETERAL STENT; STENT, URETERAL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Discomfort (2330)
Event Date 10/27/2022
Event Type  Injury  
Manufacturer Narrative
The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Imdrf patient code (b)(6) captures the reportable event of hemorrhage major.Imdrf patient code (b)(6) captures the reportable event of infection.Imdrf patient code (b)(6) captures the reportable event of discomfort.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.Imdrf impact code f08 captures the reportable event of hospitalization.
 
Event Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was placed during an unknown procedure on an unknown date.After the procedure, on (b)(6) 2022, the patient experienced an infection, bleeding and discomfort that resulted in hospitalization.The patient symptoms resolved after an unplanned stent removal performed under sedation.No further information has been obtained despite good faith efforts.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key16522983
MDR Text Key311129941
Report Number3005099803-2023-01085
Device Sequence Number1
Product Code FAD
Combination Product (y/n)N
Reporter Country CodeCS
Number of Events Reported1
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 03/10/2023
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? No
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 Received03/10/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
-
-