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

Model Number	M0061921220
Medical Device Problem Codes	Break (1069); Calcified (1077)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 stent was removed from the ureter during an unpalrigid ureteroscopic lithotomy procedure in the ureter, performed on (b)(6) 2019.On (b)(6) 2019, polaris ultra stent was implanted in the ureter.According to the complainant, during the unplanned stent removal, it was noticed on a flexible ureteroscope that the stent was broken into half along the shaft.Another polaris ultra stent was implanted to the patient and successfully completed the procedure.There was no serious injury, nor were there any adverse patient effects reported as a result of this event.The condition of the patient at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra stent was removed from the ureter during a rigid ureteroscopic lithotomy procedure in the ureter, performed on (b)(6) 2019.On (b)(6) 2019, polaris ultra stent was implanted in the ureter.According to the complainant, during the unplanned stent removal, it was noticed on a flexible ureteroscope that the stent was broken into half along the shaft.There was no serious injury, nor were there any adverse patient effects reported as a result of this event.The condition of the patient at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Problem code and device code 1069 captures the reportable event of stent shaft broken.Block h10: a polaris ultra stent was returned for analysis.A visual evaluation of the returned device found that shaft was stretched and detached.Additionally, the stent was received with calcification at several locations and other residues were observed inside of the extrusion.Based on product analysis, and all compiled information, the issue occured during theprocedure (withdrawal/closure), no issues were reported by the user during the unpacking, preparation and introduction.Moreover, the stent was returned with calcification residues and the section detached is stretch.Therefore, it is possible that removing the stent with calcification difficult the stent removal, as a resulting in the stent stretch / detached.Therefore, 'adverse event related to patient condition' is selected as the most probable root cause for the complaint.A review of the device history record (dhr) confirmed that the accepted device met all manufacturing specifications.A search of the complaint database confirmed that no similar complaints exist for the specified batch.

• 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: 8684095
• Report Number: 3005099803-2019-02862
• Device Sequence Number: 16670028
• Product Code: FAD
• UDI-Device Identifier: 08714729124306
• UDI-Public: 08714729124306
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K010002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/13/2021
• Device Model Number: M0061921220
• Device Catalogue Number: 192-122
• Device Lot Number: 0022513508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Weight: 73