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

Model Number	M0061921340
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2018
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 a polaris ultra stent was to be used for a ureteroscopy with stent placement procedure performed in the ureter on (b)(6) 2018.According to the complainant, during preparation, before the stent was inserted into the patient, the stent broke when they attempted to remove the suture from the stent.The procedure was completed with another polaris ultra stent.There were no serious injuries 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 fine.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
(b)(4).A polaris ultra stent was returned for evaluation.A visual evaluation of the returned device found that the bladder pigtail and the middle section of the stent were found detached.The detached section was located in a side port hole.The suture string was not returned for analysis.Based on the product analysis, it was determined that the failure encountered (stent detached) may have to be related to the suture string manipulation during its removal, the stent detached found is consistent with damage that is normally caused when the suture is being pulled incorrectly or with excess of force.Therefore the most probable root cause for this event is cause traced to component failure.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.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra stent was to be used for a ureteroscopy with stent placement procedure performed in the ureter on (b)(6) 2018.According to the complainant, during preparation, before the stent was inserted into the patient, the stent broke when they attempted to remove the suture from the stent.The procedure was completed with another polaris ultra stent.There were no serious injuries 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 fine.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• 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: 8127254
• Report Number: 3005099803-2018-61733
• Device Sequence Number: 19398619
• Product Code: FAD
• UDI-Device Identifier: 08714729124467
• UDI-Public: 08714729124467
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K010002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2018

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: 10/18/2020
• Device Model Number: M0061921340
• Device Catalogue Number: 192-134
• Device Lot Number: 0021280160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 12/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1