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

Model Number M0061921320

Device Problems Entrapment of Device (1212); Material Deformation (2976)

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

Event Date 10/12/2021

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a ureteroscopic lithotripsy procedure in the left ureter, performed on (b)(6) 2021.During the procedure, when the physician attempted to insert the guidewire, it was suck and couldn't be pushed.Another polaris ultra ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of stent deformed inside the patient.

Manufacturer Narrative

(b)(4).The returned polaris ultra ureteral stent was analyzed, and a visual evaluation noted that the bladder pig tail and the renal pig tail stretch, moreover, the bladder pig tail was deformed.A functional evaluation noted that a mandrel 0.035" was loaded into the device and no resistance was felt.No other issues with the device were noted.The reported event was not confirmed.According to product analysis, the device found with the bladder pig tail and the renal pig tail stretch, moreover, the bladder pigtail deformed.It is possible that operational factors, such as the force used when the stent is pushed up with the pusher/positioner over the guidewire or when the stent was used, excess force was applied and could cause the found issues, consequently affect the performance of the device.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.

Event Description

It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a ureteroscopic lithotripsy procedure in the left ureter, performed on (b)(6) 2021.During the procedure, when the physician attempted to insert the guidewire, it was suck and couldn't be pushed.Another polaris ultra ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of stent deformed inside the patient.Please see block h10 for full investigation details.

Manufacturer Narrative

Correction: h6: evaluation conclusion code.H10: investigation summary.Block h6: medical device problem code a0406 captures the reportable investigation result of stent material deformation.Block h10: the returned polaris ultra ureteral stent was analyzed, and a visual evaluation noted that the bladder pig tail and the renal pig tail stretch, moreover, the bladder pig tail was deformed.A functional evaluation noted that a mandrel 0.035" was loaded into the device and no resistance was felt.No other issues with the device were noted.The reported event was not confirmed.According to product analysis, the device found with the bladder pig tail and the renal pig tail stretch, moreover, the bladder pigtail deformed.It is possible that operational factors, such as the force used when the stent is pushed up with the pusher/positioner over the guidewire or when the stent was used, excess force was applied and could cause the found issues, consequently affect the performance of the device.It is important to mention that during product analysis the device was tested and mandrel 0.035" were inserted through the catheter and no resistance was felt and the mandrel was unloaded without issues.Therefore, adverse event related to procedure 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13239584
• MDR Text Key: 284712363
• Report Number: 3005099803-2022-00047
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729124429
• UDI-Public: 08714729124429
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K010002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/24/2023
• Device Model Number: M0061921320
• Device Catalogue Number: 192-132
• Device Lot Number: 0026565854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1