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

Model Number M0061921230

Device Problems Break (1069); Calcified (1077); Difficult to Remove (1528); Obstruction of Flow (2423); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

Note: this report is one of two complaints that pertain to the same event (mfr report # 3005099803-2021-03020 and mfr.Report #3005099803-2021-02928 ).It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a lithotripsy procedure in the ureter, performed on (b)(6) 2021.During a planned stent removal, performed on (b)(6) 2021, it was noticed that calcification on the surface of the left and right d-j ureteral stent were present.The presence of the stones led to the stiffness of the ureteral stents which made it difficult to remove.The left d-j ureteral stent was pulled out after several attempts.When the right d-j ureteral stent was attempted to be removed, resistance was large and the stent was broken from the middle section.A second procedure was performed and both stents were successfully removed in its entirely with a pair of forceps.Another polaris ultra ureteral stent was implanted and completed the procedure.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.

Manufacturer Narrative

Block e1: initial reporter state: (b)(6).Block h6: medical device problem code a040501 captures the reportable event of stent calcified.Medical device problem code a150207 captures the reportable event of stent difficult to remove.Medical device problem code a0401 captures the reportable event of stent shaft break.Medical device problem code a1409 captures the reportable investigation result of system occluded/blocked.Medical device problem code a0501 captures the reportable investigation result of stent coil detached/separated.Block h10: the returned polaris ultra ureteral stent was analyzed, and a visual evaluation noted that the distal section calcified and the proximal pigtail was detached (the detached part was missing).A functional test was performed and the stent was found occluded.The suture string and the positioner were not returned for the analysis.No other issues with the device were noted.The reported event was confirmed.According to the product analysis, the device had calcified the distal section.The device was totally occluded due to the calcification presence in the stent.Based on the information available the stent was removed after it had been placed for almost a month; the calcification could have generated that the physician had difficult to remove the device implanted.The device was found with the proximal section bladder pigtail detached, it could had been caused due to the several attempts to remove the device.These problems were documented as adverse event related to procedure.Therefore, known inherent risk of device 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.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.Correction to block g2: report source: foreign source: china.

Event Description

Note: this report is one of two complaints that pertain to the same event (mfr report # 3005099803-2021-03020 and mfr.Report #3005099803-2021-02928 ).It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a lithotripsy procedure in the ureter, performed on (b)(6) 2021.During a planned stent removal, performed on (b)(6) 2021, it was noticed that calcification on the surface of the left and right d-j ureteral stent were present.The presence of the stones led to the stiffness of the ureteral stents which made it difficult to remove.The left d-j ureteral stent was pulled out after several attempts.When the right d-j ureteral stent was attempted to be removed, resistance was large and the stent was broken from the middle section.A second procedure was performed and both stents were successfully removed in its entirely with a pair of forceps.Another polaris ultra ureteral stent was implanted and completed the procedure.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.

Event Description

Note: this report is one of two complaints that pertain to the same event (mfr report # 3005099803-2021-03020 and mfr.Report #3005099803-2021-02928 ).It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a lithotripsy procedure in the ureter, performed on january 29, 2021.During a planned stent removal, performed on (b)(6), 2021, it was noticed that calcification on the surface of the left and right d-j ureteral stent were present.The presence of the stones led to the stiffness of the ureteral stents which made it difficult to remove.The left d-j ureteral stent was pulled out after several attempts.When the right d-j ureteral stent was attempted to be removed, resistance was large and the stent was broken from the middle section.A second procedure was perfomed and both stents were successfully removed in its entirely with a pair of forceps.Another polaris ultra ureteral stent was implanted and completed the procedure.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.

Manufacturer Narrative

Block e1: initial reporter state: (b)(6) block h6: medical device problem code a040501 captures the reportable event of stent calcified.Medical device problem code a150207 captures the reportable event of stent difficult to remove.Medical device problem code a0401 captures the reportable event of stent shaft break.Block h10: the returned polaris ultra ureteral stent was analyzed, and a visual evaluation noted that the distal section calcified and the proximal pigtail was detached (the detached part was missing).A functional test was performed and the stent was found occluded.The suture string and the positioner were not returned for the analysis.No other issues with the device were noted.The reported event was confirmed.According to the product analysis, the device had calcified the distal section.The device was totally occluded due to the calcification presence in the stent.Based on the information available the stent was removed after it had been placed for almost a month; the calcification could have generated that the physician had difficult to remove the device implanted.The device was found with the proximal section bladder pigtail detached, it could had been caused due to the several attempts to remove the device.These problems were documented as adverse event related to procedure.Therefore, known inherent risk of device 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.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

• 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: 12070351
• MDR Text Key: 260472283
• Report Number: 3005099803-2021-02928
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729124320
• UDI-Public: 08714729124320
• 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,Followup
• Report Date: 08/26/2021

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: 07/03/2023
• Device Model Number: M0061921230
• Device Catalogue Number: 192-123
• Device Lot Number: 0025669393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Initial Date Manufacturer Received: 05/31/2021
• Initial Date FDA Received: 06/25/2021
• Supplement Dates Manufacturer Received: 07/29/2021; 08/24/2021
• Supplement Dates FDA Received: 08/20/2021; 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR