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

Model Number	M006192121090
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2019 as no event date was reported.(b)(6).(b)(4).The analysis of the returned product revealed: the stent was returned with the proximal section (stent shaft) detached; consequently, confirming the reported complaint.It is important to mention the protective tube was not returned in the stent.During product record review the following was performed: the device history record review was performed and no anomalies were observed, the review confirmed that the device met all manufacturing specifications and boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.Based in the dhr review, during manufacturing process the units are inspected in order to detect or avoid defects as per cosmetic procedure, bsc, ver ae, however, there is no control in how devices are handled in the field.Additionally, the stent returned without the protective tube, it is evidence of the stent was manipulated.Therefore, the failure found (stent shaft detached) is an 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.Risk review was performed according with (b)(4), polaris ultra ureteral stent rawb, bsc, at, and no unanticipated or new hazardous situation were found.All compiled information on this investigation determines that the most probable cause is: adverse event related to procedure.No further escalation is required.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a procedure performed on an unknown date.According to the complainant, during the procedure the coil detached.The procedure was completed with another of the same device.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.This event has been deemed a reportable event based on the investigation results; stent shaft break.

• 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: 9384997
• Report Number: 3005099803-2019-05654
• Device Sequence Number: 14008172
• Product Code: FAD
• UDI-Device Identifier: 08714729124290
• UDI-Public: 08714729124290
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/27/2019

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: 10/31/2019
• Device Model Number: M006192121090
• Device Catalogue Number: 192-121-09
• Device Lot Number: 0020285120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2019
• Initial Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1