MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NEPHROMAX KIT; CATHETER, NEPHROSTOMY

Model Number	M0062101600
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	07/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blocks d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: device code a0414 captures the reportable event of balloon torn material.
Event or Problem Description
It was reported that a nephromax nephrostomy balloon catheter device was used during a percutaneous nephrolithotomy (pcnl) procedure.During the procedure, after the patient underwent right percutaneous nephrolithotomy (pcnl) the nephrostomy tube fell apart where the tubing meets the luer lock hub.Reportedly, it was found that the tube near the hub was broken and it was noticing a leakage from the tube.This requires replacing the tube and the patient felt discomfort as a result of this event.
Additional Manufacturer Narrative
Ditional information: block a2, block b5 (describe event or problem), block e1, block e3 and block h6.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Device codes a0401 and a050401 has been updated to capture that this event will no longer be reportable.
Event or Problem Description
It was reported that a nephromax nephrostomy balloon catheter device was used during a percutaneous nephrolithotomy (pcnl) procedure.During the procedure, after the patient underwent right percutaneous nephrolithotomy (pcnl) the nephrostomy tube fell apart where the tubing meets the luer lock hub near the junction where the blue nephrostomy tube meets the white connector/hub and there was leakage.The procedure was completed with another of the same device with no patient complications.The patient only felt discomfort but was stable at the conclusion of the procedure.

• Brand Name: NEPHROMAX KIT
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23318485
• Report Number: 2124215-2025-73543
• Device Sequence Number: 20117598
• Product Code: LJE
• UDI-Device Identifier: 08714729834540
• UDI-Public: (01)08714729834540
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K121614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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: M0062101600
• Device Catalogue Number: M0062101600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 11/21/2025
• 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 Age: 81 YR
• Patient Sex: Male