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

Model Number	M0061921340
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2020
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 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 ureteroscopic lithotripsy (urs) procedure in the right ureter performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, after stent insertion failure, the bladder coil was torn.The procedure was successfully completed with another polaris ultra ureteral stent.There were no patient complications after this event.The patient's condition at the conclusion of the procedure was reported to be good.
Additional Manufacturer Narrative
Block h6: device code 4008 captures the reportable event of stent torn inside the patient.Block h10: the returned polaris ultra ureteral stent was analyzed, and a visual evaluation noted that the proximal section, bladder pigtail at suture hole, was torn.The suture string was not returned for analysis.No other issues with the device were noted.The reported event was confirmed.The returned polaris ultra ureteral stent revealed that the proximal section was torn.There is no control in how devices are handled in the field.The stent returned without the suture string, evidence that the stent was manipulated.Therefore, the failure found, torn bladder pigtail at suture hole, is an issue that could have been generated by the user or due to the interaction of the device with the suture string.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.A complaint with a cause of adverse event related to procedure indicates that the adverse event occurred during the preparation for the procedure and the device had no influence on the event.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 ureteroscopic lithotripsy (urs) procedure in the right ureter performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, after stent insertion failure, the bladder coil was torn.The procedure was successfully completed with another polaris ultra ureteral stent.There were no patient complications after 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: 10547211
• Report Number: 3005099803-2020-03909
• Device Sequence Number: 16892192
• Product Code: FAD
• UDI-Device Identifier: 08714729124467
• UDI-Public: 08714729124467
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K010002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2020

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: 01/08/2023
• Device Model Number: M0061921340
• Device Catalogue Number: 192-134
• Device Lot Number: 0025013915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 10/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR