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

Model Number	M0061921350
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter state: (b)(6).(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 mdr 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 stenting procedure in the right ureter performed on (b)(6) 2021.During the procedure, when the physician pushed the stent using the positioner, the stent coil became buckled and was unable to insert the stent.The procedure was successfully completed with another polaris ultra 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 good.
Additional Manufacturer Narrative
Block e1: initial reporter state: (b)(6).Block h6: medical device code a0406 captures the reportable event of stent buckled inside the patient.Block h10: the returned polaris ultra ureteral stent was analyzed, and a visual evaluation noted that the bladder pigtail section buckled accordion.No other problems with the device were noted.The reported event of was confirmed.According to the analysis performed to the photo attached and the visual assessment, the device has the bladder pigtail section buckled accordion, however, this failure is known to be generated due to the force used when the stent is pushed up with the pusher or positioner over the guidewire or when the stent was removed, moreover, the device was returned without the suture string, this is evidence that the device was manipulated, therefore, it is the most likely that it was generated due to the manipulation of the device or due to the interaction with other devices during the procedure.It's important to mention that during analysis the photo, it was observed the device out of the package and only the pigtails were observed.Review and analysis of all available information indicated that the root cause of the problems found is adverse event related to procedure is selected as the most probable 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 stenting procedure in the right ureter performed on (b)(6) 2021.During the procedure, when the physician pushed the stent using the positioner, the stent coil became buckled and was unable to insert the stent.The procedure was successfully completed with another polaris ultra 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 good.

• Brand Name: POLARIS ULTRA
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12338803
• Report Number: 3005099803-2021-04017
• Device Sequence Number: 2753827
• Product Code: FAD
• UDI-Device Identifier: 08714729124498
• UDI-Public: 08714729124498
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K010002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2021

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: 05/09/2021
• Device Model Number: M0061921350
• Device Catalogue Number: 192-135
• Device Lot Number: 0022103782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR