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

Model Number	M0061921220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The analysis of the returned product revealed: the returned stent was found with the shaft break/separated; consequently, confirming the reported complaint.The suture was not returned for analysis during product record review the following was performed: a dhr review was performed and no related deviations within manufacturing processes were found.Risk review passing results: a risk review of the polaris ultra stent 5fx24cm w/o wire was completed, polaris ultra ureteral stent rawb, bsc, at and confirmed that the event of the ar stent shaft break was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based in the dhr review, during manufacturing process the units are inspected in order to detect or avoid defects, cosmetic procedure, bsc, ver ae, package inspect and label accountability, bsc, ver bt, however, there is no control in how devices are handled in the field.Therefore, the failures found (stent break/separated) is issue that could have been generated by the user or due to the interacting of the device with the suture string.The most probable cause of this complaint is adverse event related to procedure since it is the most likely that the adverse event occurred during the preparation and the device had no influence on event.All compiled information on this investigation determines that the most probable cause is: adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2019 that a polaris ultra ureteral stent was used during a ureteroscopy procedure performed on (b)(6) 2019.According to the complainant when the wire was removed from the stent the stent broke in half.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; 100 boston scientific way; marlborough MA 01752 1242
• MDR Report Key: 9446850
• Report Number: 3005099803-2019-05990
• Device Sequence Number: 19387957
• Product Code: FAD
• UDI-Device Identifier: 08714729124306
• UDI-Public: 08714729124306
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/11/2022
• Device Model Number: M0061921220
• Device Catalogue Number: 192-122
• Device Lot Number: 0023620510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 12/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1