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

Model Number	M0061603300
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a24 captures the reportable investigation results of stent shaft break.One urinary diversion stent was returned for analysis.The reported event of stent shaft break will be confirmed.During the visual, magnification inspection, and wire insertion test, it was found that the stent coil was kinked, and the stent shaft was detached, the part detached did not return.The bending or kinking during or prior to placement could damage the integrity of the stent.According to all information and evidence gathered is possible to conclude that there is evidence of unintended use related with the event reported stent kinked.It is probable that the issue 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.For that reason, this reported complaint is assigned to the as unintended use error cause or contributed to event.Regarding the detachment found in the device it may be related with some other factors such as excessive handling of the device and the technique used by the physician encountered during the procedure that could have possibly affected the device performance and its integrity.This issue should be using the code adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on the event.Therefore, all compiled information on this investigation determines that the most probable cause is unintended use error cause or contributed to event, since the interaction between the user and device, or sample, caused or contributed to the error.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A device history record (dhr) a ship history review was performed to identify the most probable lots, and a dhr review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event.
Event or Problem Description
It was reported that during procedure, the inside of the pigtail section was kinked and the guide wire could not pass through.The device was completed with another of the same device and there was no patient injury 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: 21860653
• Report Number: 2124215-2025-23163
• Device Sequence Number: 4695878
• Product Code: LJE
• UDI-Device Identifier: 08714729821144
• UDI-Public: (01)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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/17/2025

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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