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

Model Number M0061921230

Device Problems Entrapment of Device (1212); Deformation Due to Compressive Stress (2889)

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

Event Date 01/14/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a retrograde intrarenal surgery procedure in the right ureter, performed on (b)(6) 2023.During the procedure and inside the patient, the physician was unable to push the stent over the guidewire and it was noticed that the stent was crumpled inside the scope and was unable to be removed back.A different brand of stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.A photo of the complaint device was provided and showed no visual defects.The stent was in good condition.

Manufacturer Narrative

Imdrf device code a040601captures the reportable event of stent buckled material inside the patient.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16367602
• MDR Text Key: 309467057
• Report Number: 3005099803-2023-00779
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729124320
• UDI-Public: 08714729124320
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0061921230
• Device Catalogue Number: 192-123
• Device Lot Number: 0029417988
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2022
• 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 Sex: Male