Polaris™ Ultra M0061921440Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729124580), received between Jun 3, 2021 and Oct 14, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2021Detachment of Device or Device Component; Difficult to Advance; Material Split, Cut or Torn; Detachment of Device or Device Component; Difficult to Advance; Material Split, Cut or Torn

  NOTE: THIS REPORT PERTAINS TO A SENSOR WIRE AND POLARIS ULTRA STENT DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2021-05215 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT AND A SENSOR WIRE WAS USED DURING URETEROSCOPY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2021. DURING PROCEDURE CLOSURE, THE TECHNICIAN ENCOUNTERED RESISTANCE WHEN ATTEMPTING TO PULL THE GUIDEWIRE OUT AND PHYSICIAN INSTRUCTED HER TO CONTINUE. THE GUIDEWIRE TIP TORE THE ENTIRE LENGTH OF THE STENT AND THE COIL WAS DETACHED. UPON REMOVAL, IT WAS NOTED THE GUIDEWIRE COREWIRE TIP WAS BROKEN INSIDE THE PATIENT WHEN WIRE WAS BEING PULLED OUT. THE PROCEDURE WAS COMPLETED WITH A NEW POLARIS ULTRA STENT AND SENSOR WIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12636661 ↗
• InjuryJun 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA STENT WAS IMPLANTED DURING A STENT PLACEMENT PROCEDURE FOR STONE PLACEMENT MANAGEMENT AND LASER LITHOTRIPSY IN THE LEFT DISTAL URETER ON (B)(6) 2021 AS PART OF THE (B)(6) CLINICAL STUDY. ON (B)(6) 2021, A PLANNED STENT REMOVAL WAS PERFORMED. THE IMPLANTED STENT WAS SUCCESSFULLY REMOVED WITH NO DIFFICULTY VIA A CYTO/GRASPER IN THE OPERATING ROOM. ORAL PAIN CONTROL WAS GIVEN TO THE PATIENT. THERE WAS NO NEW DEVICE IMPLANTED. THE PATIENT'S CONDITION FOLLOWING THE REMOVAL PROCEDURE IS REPORTED TO BE STABLE. ON (B)(6) 2021, THE PATIENT WAS HOSPITALIZED DUE TO A URINARY TRACT INFECTION. THE PATIENT WAS GIVEN ANTIBIOTICS AND HOSPITALIZED OVERNIGHT DUE TO THE URINARY TRACT INFECTION. THE EVENT WAS CONSIDERED TO BE RESOLVED AS OF (B)(6) 2021 AND WAS DISCHARGED FROM THE HOSPITAL. IN THE PHYSICIAN'S ASSESSMENT, THE RELATIONSHIP BETWEEN THE PROCEDURE AND THE URINARY TRACT INFECTION IS UNLIKELY RELATED AND THE RELATIONSHIP BETWEEN THE DEVICE AND THE URINARY TRACT INFECTION IS POSSIBLE.

  Patient problems: Urinary Tract Infection

  MAUDE report 11930101 ↗