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

Model Number	M006155231090
Medical Device Problem Codes	Calcified (1077); Difficult to Remove (1528); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).
Event or Problem Description
Note: this report is one of two complaints that pertain to the same event (mfr report #3005099803-2022-04953).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 performed on (b)(6) 2022.Post procedure, on (b)(6) 2022, a planned stent removal procedure was performed.When the physician attempted to remove the stent in the left ureter with a pair of biopsy forceps, it was found that the stent was calcified and the shaft was completely separated from the coils.The stent implanted in the right ureter was also attempted to be removed but there was resistance and was difficult to remove.The right ureteral stent was also found calcified.The patient was later transferred to another facility to perform an extracorporeal shock wave lithotripsy procedure to crush the stones and remove the calcified stent that was left in the patient's body.It was reported that the patient required regular ureteral stent replacement due to ureteral stenosis and was originally prone to stone adhesion.The stone encrusted to the coil in the ureter and on the pelvic side of the renal pelvis was large that removal became difficult in this attempt.It was also reported that the stent was still able to drain even though it was found encrusted and the physician commented that stent calcification was a patient problem and was not considered to be caused by the product.There were no information if the stents were successfully removed from the patient and if a new stent was implanted.

• 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: 15370468
• Report Number: 3005099803-2022-04961
• Device Sequence Number: 13884727
• 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
• 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): 09/07/2022

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 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: 08/15/2022
• Initial Report FDA Received Date: 09/07/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown