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

Model Number	M0061552230
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(6).Medical device code a0401captures the reportable event of stent shaft broken.Additional mfr narrative: the returned polaris loop ureteral stent was analyzed, a visual evaluation noted that the stent shaft was detached.The suture returned unloaded and cut, the positioner was in good condition.Also, the renal coil was kinked.During the functional analysis, a use of a mandrel 0.0339 passed through the stent without resistance.A photo of the complaint device was provided and showed that in the inner bag the stent shaft was detached, the renal coil was kinked (irregular shape), and the suture was observed unloaded and cut.Finally, during magnification, it was observed closely at the section where the device got detached and kinked.Therefore, the reported complaint of 'stent shaft break' is confirmed.No other problems with the device were noted.The reported event was confirmed.Analysis of the returned device found that the stent shaft detached and the suture returned unloaded and cut, evidence that the suture was removed and the stent was used.It is possible during the operational factors interacting with the suture string, excess of force applied such as an entanglement before use could have caused the detachment.Additionally, the problem of renal coil kinked could be due to the interacting/handling of the device during the unpacking or during the setting up of the device, these conditions could have contributed with the found problems.Consequently, affecting the performance of the device.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.
Event or Problem Description
It was reported to boston scientific corporation that a polaris loop ureteral stent was used during a lithotripsy by flexible ureteroscopy procedure in the left ureter performed on (b)(6) 2023.During unpacking, it was found that the device was fractured.The procedure was successfully completed with another polaris loop 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 stable.A photo of the complaint device was provided and showed that the stent shaft was broken.
Additional Manufacturer Narrative
Block e1: initial reporter address: (b)(6) block h6: medical device code a0401captures the reportable event of stent shaft broken.Block h11: block h10 has been corrected with the updated pi analysis.The returned polaris loop ureteral stent was analyzed, a visual evaluation noted that the stent shaft was detached.The suture returned unloaded and cut, the positioner was in good condition.Also, the renal coil was kinked.During the functional analysis, a use of a mandrel 0.0339 passed through the stent without resistance.A photo of the complaint device was provided and showed that in the inner bag the stent shaft was detached, the renal coil was kinked (irregular shape), and the suture was observed unloaded and cut.Finally, during magnification, it was observed closely at the section where the device got detached and kinked.Therefore, the reported complaint of stent shaft break and stent kinked is confirmed, however the complaint suture break is not confirmed.No other problems with the device were noted.The reported event was confirmed.Analysis of the returned device found that the stent shaft detached, and the suture returned unloaded and cut, evidence that the suture was removed, and the stent was used.It is possible during the operational factors interacting with the suture string, excess of force applied such as an entanglement before use could have caused the detachment.Additionally, the problem of renal coil kinked could be due to the interacting/handling of the device during the unpacking or during the setting up of the device, these conditions could have contributed with the found problems.Consequently, affecting the performance of the device.For the reported issue suture break, it was not confirmed due to a break in their suture and was not detected during the analysis, neither a related issue with the reported allegation, additionally, the suture was found cut and not break.For this reason, the as analyze code will be no problem detected.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.
Event or Problem Description
It was reported to boston scientific corporation that a polaris loop ureteral stent was used during a lithotripsy by flexible ureteroscopy procedure in the left ureter performed on (b)(6) 2023.During unpacking, it was found that the device was fractured.The procedure was successfully completed with another polaris loop 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 stable.A photo of the complaint device was provided and showed that the stent shaft was broken.

• 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: 16334256
• Report Number: 3005099803-2023-00365
• Device Sequence Number: 6419651
• 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
• 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): 05/23/2023

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: 08/11/2024
• Device Model Number: M0061552230
• Device Catalogue Number: 155-223
• Device Lot Number: 0027823090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2021
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Weight: 70 KG