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

Model Number M0061921330

Device Problem Device-Device Incompatibility (2919)

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

Event Date 06/17/2023

Event Type  malfunction  

Event Description

It was reported that a polaris ultra ureteral stent was used during a lithotomy under rigid ureteroscope procedure in the ureter performed on (b)(6), 2023.During the procedure, the wire and the catheter was entangled together.The procedure was successfully completed with another polaris ultra ureteral stent.Investigation results revealed that the stent was torn, inside the patient, therefore this event has been deemed an mdr reportable event.Please see block h10 for full investigation details.

Manufacturer Narrative

Block e1: initial reporter facility name: (b)(6).Block h6: imdrf device code a1702 captures for the reportable investigation results of stent torn, inside the patient.Block h10: the returned polaris ultra ureteral stent was analyzed, and a visual evaluation noted that the shaft was torn.The shaft torn.During magnification, the shaft torn was observed closely.No other problems with the device were noted.The reported event of device interaction with another device was not confirmed.Taking all available information into consideration, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.Based on the analysis, evidence found with the shaft torn.The retrieval line may be removed before placement at the physician's discretion.If the retrieval line is removed using excess force, the stent can get torn during the preparation affecting the performance of the device consistently leading to device being torn.And difficulty advancing.Consequently, affecting the performance of the device.For the reported problem of device interaction with another device, it was not confirmed since the problem was not detected during the analysis.For this reason, the as analyze code will be no problem detected.Therefore, the most probable root cause is adverse event related to the procedure.

• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 5086834015
• MDR Report Key: 18007958
• MDR Text Key: 326921741
• Report Number: 3005099803-2023-05647
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729124443
• UDI-Public: 08714729124443
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/25/2023

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: M0061921330
• Device Catalogue Number: 192-133
• Device Lot Number: 0029299406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2023
• Initial Date FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2022
• 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: 45 YR
• Patient Sex: Male
• Patient Weight: 87 KG