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

Model Number M0061552330

Device Problems Break (1069); Device-Device Incompatibility (2919)

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

Event Date 10/10/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that a polaris loop ureteral stent was used during a ureteroscopic endoprosthesis placement procedure in the left ureter, performed on (b)(6), 2022.During the procedure and inside the patient, it was noted that the stent was broken in half along the shaft when the guidewire was retracted while attempting to deploy the stent.Another polaris loop ureteral stent was opened and successfully completed the procedure.There were no patient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 loop ureteral stent was used during a ureteroscopic endoprosthesis placement procedure in the left ureter, performed on (b)(6) 2022.During the procedure and inside the patient, it was noted that the stent was broken in half along the shaft when the guidewire was retracted while attempting to deploy the stent.Another polaris loop ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: medical device problem code a0401 captures the reportable event of stent shaft break.Block h10: the returned polaris loop ureteral stent was analyzed, and a visual evaluation noted that the shaft was detached.It was also observed that the stent shaft was buckled/accordion.The suture and the positioner were not returned for analysis.For functional inspection, a mandrel of 0,039" was used and it passed through the stent successfully.During the magnification, it was observed that the distal end of the shaft torn.No other problems with the device were noted.The reported event was confirmed.Based on the most relevant information of the complaint event description, device analysis and including the product record review results, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.According to the product analysis, the device was found with the shaft detached and torn, as well as buckled/accordion.Additionally, according to the event description which states "the stent was fractured when the guide wire was retracted after the internal stent was placed", it is possible to conclude that operational factors, interaction of the excess of force applied over the device during the procedure, such as the handling/manipulation during the placement of the device could have caused the failures that was observed.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.

• Brand Name: POLARIS LOOP
• 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: 15738570
• MDR Text Key: 308002638
• Report Number: 3005099803-2022-06398
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K030503
• 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: 12/30/2022

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 Model Number: M0061552330
• Device Catalogue Number: 155-233
• Device Lot Number: 0028404132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 12/07/2022
• Supplement Dates FDA Received: 12/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2021
• 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
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 65 KG