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

Model Number	M006192133090
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure 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 to boston scientific corporation that a polaris ultra ureteral stent was used during a ureteral stent implantation procedure in the ureter, performed on (b)(6) 2022.After the procedure, when the physician deployed the stent, it was noticed under a cystoscope that the pigtail was torn.The stent was removed and another polaris ultra ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device problem code a0414 captures the reportable event of stent torn material inside the patient.Block h10: the returned polaris ultra ureteral stent was analyzed, and a visual evaluation noted that the stent has a torn in their first drainage hole.Additionally, the suture did not return.During functional test a use of a mandrel of 0.39" and this pass through the stent successfully without resistance.No other issues with the device were noted.The reported event was confirmed.According to the event description and findings during the device analysis was possible to observe that the stent was manipulated and it has the first drainage hole torn.This failure could have been cause due to an interaction of the device with the suture string.If the retrieval line is removed with excess force this could compromised the integrity of the device and could have cause the tear encountered in the first drainage hole, moreover, the suture could have get entangled and contribute to the failure such as manipulation or excess of force applied during it use in the procedure, causing the torn observed.Consequently, affect the performance of the device.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a ureteral stent implantation procedure in the ureter, performed on (b)(6), 2022.After the procedure, when the physician deployed the stent, it was noticed under a cystoscope that the pigtail was torn.The stent was removed and another polaris ultra ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.

• Brand Name: POLARIS ULTRA
• 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: 14835343
• Report Number: 3005099803-2022-03381
• Device Sequence Number: 2351407
• Product Code: FAD
• UDI-Device Identifier: 08714729124450
• UDI-Public: 08714729124450
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K010002
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2022

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: 01/05/2025
• Device Model Number: M006192133090
• Device Catalogue Number: 192-133-09
• Device Lot Number: 0029090262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2022
• 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