MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX URINARY DIVERSION STENT; CATHETER, NEPHROSTOMY

Model Number	M0061603250
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a percuflex urinary diversion stent was to be used in a procedure.During unpacking, a small debris-like piece was found inside the packaging.The procedure was completed with another of the same device and there were no patient complications reported.
Additional Manufacturer Narrative
Block b3: event date: approximated based on the date the manufacturer became aware of the event.Block h6: device code a180104 captures the reportable event of device foreign material present in device.
Additional Manufacturer Narrative
Block b3: event date: approximated based on the date the manufacturer became aware of the event.Block h6: device code a180104 captures the reportable event of device foreign material present in device.Block h11: investigation analysis the returned urinary diversion ureteral stent with other parts of the kit and the pouch was analyzed, and during the inspection no damage was found, which did not confirm the reported event.Based on the most relevant information, the reported "device foreign material present in device", after visual, microscope and functional inspections in the complaint device, it was not possible to identify any evidence of either the alleged issue or any defect on the device.Also, the evidence from the product record review did not identify a potential product quality issue or new patient harm.A review of the device history record (dhr) indicated that the device met all material, assembly, and product specifications at the time of release to distribution.A risk review was completed and confirmed that the event of "device foreign material present in device" was defined in the risk documentation.Based on the results of the device evaluation, an investigation conclusion code of device problem excluded was assigned to this investigation.
Event or Problem Description
It was reported that a percuflex urinary diversion stent was to be used in a procedure.During unpacking, a small debris-like piece was found inside the packaging.The procedure was completed with another of the same device and there were no patient complications reported.

• Brand Name: PERCUFLEX URINARY DIVERSION STENT
• Common Device Name: CATHETER, NEPHROSTOMY
• 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: 24315250
• Report Number: 2124215-2026-07754
• Device Sequence Number: 5583574
• Product Code: LJE
• UDI-Device Identifier: 08714729821137
• UDI-Public: (01)08714729821137(17)280311(10)37676038
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K830803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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
• Operator of Device: Health Professional
• Device Model Number: M0061603250
• Device Catalogue Number: 160-325
• Device Lot Number: 0037676038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown