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

Model Number M0061552210

Device Problems Difficult to Advance (2920); Material Split, Cut or Torn (4008)

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

Event Date 12/21/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a polaris loop ureteral stent was used during a flexible ureteral lithotripsy procedure in the kidney performed on (b)(6) 2023.During the procedure, it was noted that they had difficulty advancing the stent.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.Investigation results revealed that the stent was torn, inside the patient, therefore this event has been deemed an mdr reportable event.Please see block h10 for full investigation details.

Manufacturer Narrative

Block h6: imdrf device code a0414 captures the reportable investigation results of stent torn, inside the patient.Block h10: the returned polaris loop ureteral stent was analyzed, and a visual evaluation noted that there was no visual damage found.Additionally, the suture was not returned.During microscopic inspection, the renal coil was closely observed being torn.A functional inspection was performed and a mandrel of 0.039 was loaded into the device and no resistance was felt.No other problems with the device were noted.The reported event of stent difficult to advance was not confirmed.Taking all available information into consideration, most likely, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.Based on the analysis performed, it may be related with some other factors such as excessive handling of the device, the technique used by the physician and normal procedural difficulties encountered during the procedure that could have possibly affected the device performance and its integrity.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: 18790449
• MDR Text Key: 337531759
• Report Number: 2124215-2024-09702
• Device Sequence Number: 1
• Product Code: FAD
• 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: 02/27/2024

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: M0061552210
• Device Catalogue Number: 155-221
• Device Lot Number: 0029982526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2022
• 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: 48 YR
• Patient Sex: Male
• Patient Weight: 86 KG