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

Model Number M0061921320

Device Problems Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)

Patient Problems Discomfort (2330); Insufficient Information (4580)

Event Date 03/10/2024

Event Type  Injury  

Event Description

Note: this report is one of two complaints that pertain to the same event (mfr report #2124215-2024-19098 and mfr.Report #2124215-2024-19110).It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a flexible ureterolithomy 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 became complicated, 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.

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of stent buckled material, inside the patient.Imdrf impact code f05 captures the reportable event of delay to treatment.

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of stent buckled material, inside the patient.Imdrf impact code f05 captures the reportable event of delay to treatment.Update to block f10, block h6: discomfort.

Event Description

It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a flexible ureterolithomy 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 became complicated, 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.

• Brand Name: POLARIS ULTRA
• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19053008
• MDR Text Key: 339548197
• Report Number: 2124215-2024-19098
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729124429
• UDI-Public: 08714729124429
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K010002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/14/2024

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
• Device Operator: Health Professional
• Device Model Number: M0061921320
• Device Catalogue Number: 192-132
• Device Lot Number: 0031883408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 05/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention