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

Model Number M0061921330

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/13/2024

Event Type  malfunction  

Manufacturer Narrative

Block e1: initial reporter address: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of stent shaft break.

Event Description

It was reported to boston scientific corporation that a polaris ultra ureteral stent was used to treat ureteral calculi during a holmium laser lithotripsy procedure in the ureter performed on (b)(6) 2024.During unpacking, the device was found fractured.It was noted that the stent was broken into two pieces along the shaft.The procedure was successfully completed with another polaris ultra ureteral stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block e1: initial reporter address: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of stent shaft break.Block h10: the returned polaris ultra ureteral stent was analyzed, and upon magnification it was observed that the shaft detached closed to the bladder coil.Additionally, the positioner was returned in good condition and the suture was not returned.No other problems with the device were noted.The reported event was confirmed.With all the available information, boston scientific concludes that the reported event was confirmed.The device meets all manufacturing specifications required and passed all the controls and inspections; no abnormalities were reported during the assembly process.It is possible to concluded that this problem could be caused by operational factors.The retrieval line may be removed before placement at the physician's discretion.If the retrieval line is removed using excess force, the stent can get detached during the manipulation of the device affecting the performance of the device.Therefore, all compiled information on this investigation determines that the most probable cause is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.

Event Description

It was reported to boston scientific corporation that a polaris ultra ureteral stent was used to treat ureteral calculi during a holmium laser lithotripsy procedure in the ureter performed on (b)(6) 2024.During unpacking, the device was found fractured.It was noted that the stent was broken into two pieces along the shaft.The procedure was successfully completed with another polaris ultra ureteral stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 19093817
• MDR Text Key: 340107508
• Report Number: 2124215-2024-21136
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729124443
• UDI-Public: 08714729124443
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 04/11/2024

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
• Device Operator: Health Professional
• Device Model Number: M0061921330
• Device Catalogue Number: 192-133
• Device Lot Number: 0031883413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2023
• 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 Age: 43 YR
• Patient Sex: Male
• Patient Weight: 76 KG