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

Model Number M0061921320

Device Problems Break (1069); Entrapment of Device (1212); Deformation Due to Compressive Stress (2889); Material Deformation (2976)

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

Event Date 11/01/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a ureteroscopy procedure in the kidney on an unknown date.During the procedure, it was noted that the stent was stuck to the wire.The procedure was successfully completed with another polaris ultra ureteral stent.There were no patient complications reported as a result of this event.The device has not been returned for analysis.

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a ureteroscopy procedure in the kidney on an unknown date.During the procedure, it was noted that the stent was stuck to the wire.The procedure was successfully completed with another polaris ultra ureteral stent.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: medical device code a040601 captures the reportable event of stent buckled.Block h10: the returned polaris ultra ureteral stent was analyzed, and a visual evaluation noted that the device was observed with residues.Additionally, their suture and positioner were not returned.No more problems detected.No other issues with the device were noted.The reported event was not confirmed.Based on the most relevant information of the complaint event description, device analysis and including the product record review results, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.It was found that device has residues along the stent as part of the procedure.Most likely, some operational factors, interaction of the excess force during interaction with the guide wire during the procedure of the device could have caused that the device got stuck.However, the reported issues of device guidewire stuck, stent.Kinked, stent buckled material and suture break are not confirmed due to this issue and were not detected during the analysis and neither a related issue with the reported allegation.Therefore, all compiled information on this investigation determines that the most probable cause is no problem detected since the device complaint or problem cannot be confirmed.

• 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: 15857062
• MDR Text Key: 304556811
• Report Number: 3005099803-2022-06865
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729124443
• UDI-Public: 08714729124443
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2023

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: M0061921320
• Device Catalogue Number: 192-133
• Device Lot Number: 0029682284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 11/23/2022
• Supplement Dates Manufacturer Received: 12/20/2022
• Supplement Dates FDA Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2022
• 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