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

Model Number	M0061552310
Medical Device Problem Codes	Difficult to Remove (1528); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device code: (b)(4).Medical device code: (b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a polaris loop ureteral stent was implanted during an ureteroscopic lithotripsy procedure performed on (b)(6) 2022.The patient was stented with a polaris loop ureteral stent 6x22cm and for around one month, a removal procedure was performed on (b)(6) 2022.During procedure, when the physician attempted to removed the implanted polaris loop ureteral stent, it was found that the coil part migrated to the patient's ureteric office.They were unable to remove the migrated coil with forceps, therefore the physician inserted cystoscope in order to view and was able to removed the migrated coil successfully.The patient's condition at the conclusion of the procedure was reported to be as "patient does not feel any unusual pain".The device has not been returned for analysis.No further information has been obtained despite good faith efforts.

• 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: 13981930
• Report Number: 3005099803-2022-01545
• Device Sequence Number: 12273023
• Product Code: FAD
• UDI-Device Identifier: 08714729421078
• UDI-Public: 08714729421078
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/01/2022

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 Expiration Date: 05/31/2024
• Device Model Number: M0061552310
• Device Catalogue Number: 155-231
• Device Lot Number: 0027411089
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• 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
• Patient Sex: Female