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

Model Number M0061921310

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 02/26/2024

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a1802 captures the reportable event of packaging foreign matter.

Event Description

It was reported to boston scientific corporation that a polaris ultra ureteral stent was opened to be used during a ureteroscopy procedure performed on (b)(6) 2024.During preparation.The device tip was found sticky.It was noted that the packaging was normal.The procedure was successfully completed with another polaris ultra ureteral stent.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 opened to be used during a ureteroscopy procedure performed on (b)(6) 2024.During preparation.The device tip was found sticky.It was noted that the packaging was normal.The procedure was successfully completed with another polaris ultra ureteral stent.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a1802 captures the reportable event of packaging foreign matter.Block h10: the returned polaris ultra ureteral stent was analyzed, and a visual and microscopic evaluation noted that the bladder coil detached, and the suture hole torn.There was not possible to see any foreign material in the pouch.No other problems with the device were noted.The reported event was not confirmed.Taking all available information into consideration, most likely, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.For the reported problem of packaging foreign material, it is not confirmed due to a foreign material was not detected in the pouch during the analysis.For this reason, the as analyze code will be no problem detected.It is possible to conclude that this problem could be caused by operational factors.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 detached and torn during the preparation affecting the performance of the device.Therefore, all compiled information on this investigation determines that the most probable cause is "adverse event related to procedure" since the adverse event occurred during the procedure and the device had no influence on event.

• 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
• MDR Report Key: 18965351
• MDR Text Key: 338615293
• Report Number: 2124215-2024-15880
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729124405
• UDI-Public: 08714729124405
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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,Followup
• Report Date: 05/07/2024

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: M0061921310
• Device Catalogue Number: 192-131
• Device Lot Number: 0032275683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/23/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 05/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2023
• 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: Female