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

Model Number M0061552230

Device Problem Break (1069)

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

Event Date 03/27/2024

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of stent shaft broken.

Event Description

It was reported to boston scientific corporation that a polaris loop ureteral stent was used during a ureteral lithotomy procedure in the ureter performed on march 27, 2024.During preparation, when the device was unpacked, the stent was found fractured.The procedure was successfully completed with another polaris loop 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.A photo of the complaint device was provided and showed that the distal end of the stent shaft was broken.

Event Description

It was reported to boston scientific corporation that a polaris loop ureteral stent was used during a ureteral lithotomy procedure in the ureter performed on (b)(6) 2024.During preparation, when the device was unpacked, the stent was found fractured.The procedure was successfully completed with another polaris loop 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.A photo of the complaint device was provided and showed that the distal end of the stent shaft was broken.

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of stent shaft broken.Block h10: the returned polaris loop ureteral stent was analyzed, and a visual and microscopic evaluation noted that the shaft was detached.Additionally, the suture and positioner were not returned.No other problems with the device were noted.Taking all available information into consideration, most likely, it is possible to conclude that this problem could be caused by operational factors.The retrieval line may be removed before placement at the physicians discretion.If the retrieval line is removed using excess force and entangled in the shaft, the stent can get detached during the preparation 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.

• Brand Name: POLARIS LOOP
• 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: 19134715
• MDR Text Key: 340830189
• Report Number: 2124215-2024-22579
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729421030
• UDI-Public: 08714729421030
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K030503
• 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: 04/18/2024

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: M0061552230
• Device Catalogue Number: 155-223
• Device Lot Number: 0030968217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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: 29 YR
• Patient Sex: Female
• Patient Weight: 60 KG