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

Model Number	M0061921320
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Discomfort (2330)
Date of Event	03/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Note: this report is one of two complaints that pertain to the same event (mfr report # mfr.Report # 2124215-2024-19164).It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a flexible ureterolithomy plus catheter placement procedure performed on (b)(6) 2024.During the procedure, the stent did not pass through the guidewire.It was noted that the stent was buckled.The stent was soaked in water for approximately 5 to 10 minutes, however, due to the failure to pass, it had to be removed.The procedure had to be canceled because the patient was bleeding, and discomfort was experienced.It was noted that the discomfort experienced was from the specialists with the product problem.There were no additional patient complications reported.
Additional Manufacturer Narrative
Imdrf device code a0401 captures the reportable event of stent buckled material, inside the patient.Imdrf patient code e0506 captures the reportable event of bleeding.Imdrf impact code f05 captures the reportable event of delay to treatment.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent buckled material, inside the patient.Imdrf patient code e0506 captures the reportable event of bleeding.Imdrf impact code f05 captures the reportable event of delay to treatment.Update to block f10, block h6: discomfort.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a flexible ureterolithotomy plus catheter placement procedure performed on (b)(6) 2024.During the procedure, the stent did not pass through the guidewire.It was noted that the stent was buckled.The stent was soaked in water for approximately 5 to 10 minutes, however, due to the failure to pass, it had to be removed.The procedure had to be canceled because the patient was bleeding, and discomfort was experienced.A nephrostomy had to be performed for the patient's bleeding.It was noted that the discomfort experienced was from the specialists with the product problem.There were no additional patient complications reported.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent buckled material, inside the patient.Imdrf patient code e0506 captures the reportable event of bleeding.Imdrf impact code f05 captures the reportable event of delay to treatment.Block h11: the returned polaris ultra ureteral stent was analyzed, and upon magnification it was observed that no damage was found.Additionally, the suture and positioner were not returned.During functional inspection, the mandrel 0.039 was loaded into the device and no resistance was felt.The reported event was not confirmed.With all the available information, boston scientific concludes that the reported event was not confirmed.Hemorrhage and pain/discomfort may be associated with the use of the device, therefore, these events are assigned the most probable root cause classification of known inherent risk of device.The reported event of stent buckled and difficult to advance was not possible to identify any evidence of either the alleged problem or any defect on the device after functional, visual, and microscope.Therefore, this investigation is assigned a most probable conclusion code of no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a flexible ureterolithomy plus catheter placement procedure performed on (b)(6) 2024.During the procedure, the stent did not pass through the guidewire.It was noted that the stent was buckled.The stent was soaked in water for approximately 5 to 10 minutes, however, due to the failure to pass, it had to be removed.The procedure had to be canceled because the patient was bleeding, and discomfort was experienced.A nephrostomy had to be performed for the patient's bleeding.It was noted that the discomfort experienced was from the specialists with the product problem.There were no additional patient complications reported.

• Brand Name: POLARIS ULTRA
• Common Device Name: 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19047342
• Report Number: 2124215-2024-19151
• Device Sequence Number: 8483277
• Product Code: FAD
• UDI-Device Identifier: 08714729124429
• UDI-Public: 08714729124429
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K010002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2026
• Device Model Number: M0061921320
• Device Catalogue Number: 192-132
• Device Lot Number: 0031883408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/23/2024; 06/17/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 05/16/2024; 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown