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

Model Number	M0061921540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a ureteroscopy procedure in the right ureter performed on (b)(6), 2023.During preparation, upon removing the suture, the stent shaft was detached.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 good.A photo of the complaint device was provided and showed that the stent shaft was broken.
Additional Manufacturer Narrative
Age at time of event: it was reported that the patient was over 18 years old.Weight: the patient's weight is 70 to 79 kilograms.Imdrf device code a0401 captures the reportable event of stent shaft break.
Additional Manufacturer Narrative
Block a2: age at time of event: it was reported that the patient was over 18 years old.Block a4 weight: the patient's weight is 70 to 79 kilograms.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 a visual evaluation noted that the stent shaft was detached.It was also observed that some side port holes were stretch out and their suture hole torn until the tip.Their respective positioner and suture did not return.Functional analysis uses a mandrel of 0,039 and pass through stent without resistance.No other problem with the device were noted.The reported event was confirmed.Based on the most relevant information, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.Additionally, the bladder coil was found kinked, and their side port holes stretched and one torn.Most likely these failures could be generated during the preparation when the stent was loaded into the guide wire, probably some excess of force applied over the device such as the handling or operational factors caused the failure.Therefore, based in all compiled information on this investigation determines that the most probable cause is failure to follow instructions.Since problem is traced to the user not following the manufacturer's instructions.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a ureteroscopy procedure in the right ureter performed on (b)(6) 2023.During preparation, upon removing the suture, the stent shaft was detached.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 good.A photo of the complaint device was provided and showed that the stent shaft was broken.

• Brand Name: POLARIS ULTRA
• Common Device Name: 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: 16388042
• Report Number: 3005099803-2023-00793
• Device Sequence Number: 14876477
• Product Code: FAD
• UDI-Device Identifier: 08714729124702
• UDI-Public: 08714729124702
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K010002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/26/2025
• Device Model Number: M0061921540
• Device Catalogue Number: 192-154
• Device Lot Number: 0028761061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2023
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male