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

Model Number	M0061921430
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).The returned polaris ureteral stent was analyzed, and a visual evaluation noted that the middle section was detached/separated.The suture string was not returned for analysis.No other issues with the device were noted.The reported event was confirmed.Based on the product analysis, there is no control in how devices are handled in the field.Additionally, the stent returned without the suture string, it is evidence of the stent was manipulated.Therefore, the failure found (catheter break / separated) is an issue that could have been generated by the user or due to the interacting 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 review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a ureteral catheterization via cystoscope procedure in the bladder, performed on (b)(6) 2020.According to the complainant, during the procedure, when the physician unpacked the package, it was found that the polaris ultra ureteral stent was fractured.Another polaris ultra stent was opened and successfully completed the procedure.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.

• 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: 10233466
• Report Number: 3005099803-2020-02600
• Device Sequence Number: 3373793
• Product Code: FAD
• UDI-Device Identifier: 08714729124566
• UDI-Public: 08714729124566
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 07/06/2020

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: 03/06/2021
• Device Model Number: M0061921430
• Device Catalogue Number: 192-143
• Device Lot Number: 0021830127
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 07/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 65