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

Model Number	M0061921340
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and 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 polaris ultra stent was implanted in the ureter for a ureteroscopy stent placement procedure on (b)(6) 2018.According to the complainant, post procedure on (b)(6) 2018, during the planned stent removal to be completed with an in-office cystoscopy, the physician had difficulty removing the stent.The patient was referred to the hospital to have a ureteroscopy to remove the stent.The physician was able to determine that the stent had kinked in the proximal coil which had prevented it from straightening out.The entire stent was removed successfully.No additional stent was placed.There was no serious injury nor were there any adverse patient effects as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that polaris ultra stent was implanted in the ureter for a ureteroscopy stent placement procedure on (b)(6) 2018.According to the complainant, post procedure on (b)(6) 2018, during the planned stent removal to be completed with an in-office cystoscopy, the physician had difficulty removing the stent.The patient was referred to the hospital to have a ureteroscopy to remove the stent.The physician was able to determine that the stent had kinked in the proximal coil which had prevented it from straightening out.The entire stent was removed successfully.No additional stent was placed.There was no serious injury nor were there any adverse patient effects as a result of this event.
Additional Manufacturer Narrative
Problem code 1528 captures the reportable event of stent difficult to remove.Investigation results: a polaris ultra stent was returned for analysis.A visual evaluation of the returned device found that it was buckled/accordioned at the proximal section (bladder pigtail).No other anomalies were noted.A functional inspection was performed, a mandrel 0.038 inches was inserted through the catheter and resistance was met during its advancing and removing due to the section encountered as buckled/accordioned.Based on the product analysis, the device has the working length buckled.This failure is known to be generated due to the force used when the stent is pushed up with the pusher/positioner over the guidewire.It is most likely that it was generated due to the manipulation of the device or due to the interaction with other devices during the procedure.Therefore the most probable root cause for this event is adverse event related to procedure since it is most likely that the adverse event occurred during the procedure and the device had no influence on the event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.

• 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: 8127070
• Report Number: 3005099803-2018-61731
• Device Sequence Number: 1732200
• Product Code: FAD
• UDI-Device Identifier: 08714729124467
• UDI-Public: 08714729124467
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K010002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2019

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: 06/25/2021
• Device Model Number: M0061921340
• Device Catalogue Number: 192-134
• Device Lot Number: 0022301998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1