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

Model Number M0061921330

Device Problems Material Deformation (2976); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(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 Description

It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a ureteral stenting procedure in the left ureter, performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, the physician had difficulty in trying to insert the polaris ultra stent.Physician took out the stent and noticed that there was a bend in the middle.Another polaris ultra ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a ureteral stenting procedure in the left ureter, performed on (b)(6), 2020.According to the complainant, during the procedure and inside the patient, the physician had difficulty in trying to insert the polaris ultra stent.Physician took out the stent and noticed that there was a bend in the middle.Another polaris ultra ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block e1: initial reporter state: (b)(6).Block h6: device code 2976 captures the reportable event of stent kinked inside the patient.Block h10: the returned polaris ureteral stent was analyzed, the catheter returned looks in good condition, no defects or kinks were noted.Moreover, a 0.035 mandrel was inserted through the device returned and no obstruction or resistance was met during its advancing.No other issues with the device were noted.The reported event was not confirmed.Based on the product analysis of the returned device, there is no evidence of either the alleged issue or any defect which could have contributed to the event.It's important to mention that during the product analysis the device was visually and functionally tested and no issues were detected.Therefore, no problem detected is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: POLARIS ULTRA
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10631681
• MDR Text Key: 210011503
• Report Number: 3005099803-2020-04399
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729124443
• UDI-Public: 08714729124443
• Combination Product (y/n): N
• PMA/PMN Number: K010002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/02/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2023
• Device Model Number: M0061921330
• Device Catalogue Number: 192-133
• Device Lot Number: 0025261493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 10/05/2020
• Supplement Dates Manufacturer Received: 10/09/2020
• Supplement Dates FDA Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR