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

Model Number	M0061921440
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
Note: this report pertains to a sensor wire and polaris ultra stent during the same procedure.Refer to manufacturer report# 3005099803-2021-05215 for the other associated device information.It was reported to boston scientific corporation that a polaris ultra ureteral stent and a sensor wire was used during ureteroscopy procedure in the kidney performed on (b)(6) 2021.During procedure closure, the technician encountered resistance when attempting to pull the guidewire out and physician instructed her to continue.The guidewire tip tore the entire length of the stent and the coil was detached.Upon removal, it was noted the guidewire corewire tip was broken inside the patient when wire was being pulled out.The procedure was completed with a new polaris ultra stent and sensor wire.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
• MDR Report Key: 12636661
• Report Number: 3005099803-2021-05266
• Device Sequence Number: 17007443
• Product Code: FAD
• UDI-Device Identifier: 08714729124580
• UDI-Public: 08714729124580
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2021

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: 09/25/2023
• Device Model Number: M0061921440
• Device Catalogue Number: 192-144
• Device Lot Number: 0026080978
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1