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

Model Number	M0061603300
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during the transurethral ureteral stent placement procedure using the percuflex urinary diversion stent, the stent was found kinked.Another of the same device was used to successfully complete the procedure.No patient complications were reported.Analysis of the retuned device identified that the stent shaft was broken.
Additional Manufacturer Narrative
Block h6: imdrf evaluation code c070601 captures the reportable event of stent shaft break.Block h11: the returned percuflex urinary diversion stent was analyzed, and a visual evaluation noted that the stent coil was kinked, and the stent shaft was detached, the part detached did not return.Based on the most relevant information, is possible to conclude that there was evidence of unintended use related with the event reported stent kinked.It is probable that the problem was caused due to the interaction between the guidewire and the stent device as well, such as the handling of the device could have contributed with the complaint event reported.Therefore, an investigation conclusion code of unintended use error cause or contributed to event has been assigned to this investigation.

• 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: 21454738
• Report Number: 2124215-2025-10863
• Device Sequence Number: 19923512
• Product Code: LJE
• UDI-Device Identifier: 08714729821144
• UDI-Public: 08714729821144
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2025

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: M0061603300
• Device Catalogue Number: 160-330
• Device Lot Number: 0034138671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 02/24/2025
• Date Device Manufactured: 02/09/2024
• 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