FDA Adverse Event
Malfunction
Summary report: N
POLARIS? LOOP
MDR report key: 22611928
·
Received July 25, 2025
Report
- Report Number
- 2124215-2025-49602
- Event Type
- Malfunction
- Date Received
- July 25, 2025
- Date of Event
- May 13, 2025
- Report Date
- July 25, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FAD
- UDI-DI
- 08714729421030
- PMA / PMN Number
- K030503
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK H6: DEVICE CODE A040501 CAPTURES THE REPORTABLE INVESTIGATION RESULT OF STENT CALCIFIED.
Description of Event or Problem · 0
IT WAS REPORTED THAT A POLARIS LOOP URETERAL STENT WAS USED IN A URETERAL LITHOTRIPSY AND STONE REMOVAL IN THE URETER. DURING THE PROCEDURE, WHEN THE STENT WAS INSERTED, IT COULD NOT CROSS THE STENOSIS OF THE URETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED THAT THE STENT WAS CALCIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2009848 | POLARIS? LOOP | STENT, URETERAL | FAD | BOSTON SCIENTIFIC CORPORATION | M0061552230 | 0033130066 | 08714729421030 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Male |