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

Model Number	M0061552230
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	09/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a polaris loop ureteral stent was used during a ureteral stent placement procedure in the right ureter, performed on (b)(6), 2022.The patient had right ureteral stenosis.In order to remove upper urinary tract obstruction, protect renal function and alleviate clinical symptoms, right ureteral stent replacement was performed under local anesthesia.On (b)(6), 2022, it was noted that the patient had experienced right wrist pain, felt uncomfortable and pain after the stent insertion.The patient was told to drink more water and was given a medication of diclofenac sodium 50mg orally, twice a day.It was reported that the patient was brought back to the operating room at another time to have the stent exchanged.The procedure was successfully completed using a different size of polaris loop ureteral stent.The condition of the patient after three days was reported relieved.
Additional Manufacturer Narrative
Initial reporter facility name: tang county people's hospital/baoding fourth central hospital (b)(4).

• 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 CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15756305
• Report Number: 3005099803-2022-06392
• Device Sequence Number: 11992835
• Product Code: FAD
• UDI-Device Identifier: 08714729421030
• UDI-Public: 08714729421030
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/24/2024
• Device Model Number: M0061552230
• Device Catalogue Number: 155-223
• Device Lot Number: 0027382217
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female