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

Model Number	M006155231090
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2022 based on the date the manufacturer became aware of the event.The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a polaris loop ureteral stent was implanted during a ureteral stent placement procedure in the left and right ureter.The event date was unknown.During a planned stent removal procedure, 4 months after the stent was implanted, it was noticed that the stent was calcified.The calcified stent was removed from the patient and a new polaris loop ureteral stent was implanted.It was reported that the patient required regular ureteral stent replacement due to ureteral stenosis and was originally prone to stone adhesion.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: date of event was approximated to (b)(6) 2022 based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: medical device problem code a040501 captures the reportable event of stent calcified.
Event or Problem Description
It was reported to boston scientific corporation that a polaris loop ureteral stent was implanted during a ureteral stent placement procedure in the left and right ureter.The event date was unknown.During a planned stent removal procedure, 4 months after the stent was implanted, it was noticed that the stent was calcified.The calcified stent was removed from the patient and a new polaris loop ureteral stent was implanted.It was reported that the patient required regular ureteral stent replacement due to ureteral stenosis and was originally prone to stone adhesion.There were no patient complications reported as a result of this event.

• Brand Name: POLARIS LOOP
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15374971
• Report Number: 3005099803-2022-05133
• Device Sequence Number: 5402769
• Product Code: FAD
• UDI-Device Identifier: 08714729765493
• UDI-Public: 08714729765493
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K030503
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2022

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 Model Number: M006155231090
• Device Catalogue Number: 155-231-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown