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

Model Number	M006193133090
Medical Device Problem Codes	Calcified (1077); Difficult to Remove (1528); Obstruction of Flow (2423); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The returned polaris ultra ureteral stent was analyzed, and a visual evaluation noted that the stent surface was blackened at the proximal section, with the bladder pigtail detached and it was found obstructed and calcified.A photo of the device was provided and it showed that the device was blackened with the bladder pigtail detached and calcified inside of a generic plastic bag, also it was possible to observe a suture string with several knots.No other issues with the device were noted.The reported event was confirmed.Based on all the gatered information, the stent returned was calcified/occlude, partially blackened at proximal section and with the bladder pigtail detached.The stent was implanted in the patient for five months, the physician applied contrast fluid for check the device and then he removes ureteral stent.Prior to the stent placement procedure, the physician does not report any issue with the device and no other defects were noted.According to product analysis, the device was found calcified (occlude) all along of the device; moreover, based on the information available the stent was removed due to calcification condition will affect the device removal process and device performance.Therefore, the most probable cause of those failures is known inherent risk of device since reported adverse event known and documented in the labeling.The suture hole was found torn and the bladder coil detached, those failures could have been caused by the user or due to the interaction with the suture string or an excess of force during the withdrawal of the device.Those failures were documented in the coding table as adverse event related to procedure.Since the reported issue is known and documented in the labeling as a possible effect related to the effects in the device coating.Therefore, known inherent risk of device is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a procedure due to pyelonephritis in the urinary tract, performed on an unknown date in (b)(6) hospital.During a ureteral stent removal procedure performed on (b)(6) 2021, five months after the stent was implanted, the stent could not be removed.The patient was referred to (b)(6) hospital and was checked under fluoroscopy, it was noticed that the pigtail coil on the kidney side was detached in the ureter.A guidewire was tried to advance, but it could not advance.The stent was removed while following the ureteral access sheath.Another ureteral stent of a different model was used and successfully completed the procedure.There were no patient complications reported as a result of this event.A photo of the complaint device was provided and showed that the stent was calcified and the pigtail was detached/separated.

• Brand Name: POLARIS ULTRA
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12185420
• Report Number: 3005099803-2021-03529
• Device Sequence Number: 16377922
• Product Code: FAD
• UDI-Device Identifier: 08714729762928
• UDI-Public: 08714729762928
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K010002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/16/2021

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
• Operator of Device: Health Professional
• Device Model Number: M006193133090
• Device Catalogue Number: 193-133-09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR