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

Model Number	M0062101400
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a0402 captures the reportable event of balloon burst.
Event or Problem Description
It was reported that a nephromax nephrostomy balloon catheter was used during a percutaneous nephrolithotomy (pcnl) procedure.During the procedure, the balloon burst.The procedure was completed with another of the same device with no patient complications.
Event or Problem Description
It was reported that a nephromax nephrostomy balloon catheter was used during a percutaneous nephrolithotomy (pcnl) procedure.During the procedure, the balloon burst at 12 atmospheres.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block h2: additional information: block b5 (describe event or problem).Block h6: device code a0402 captures the reportable event of balloon burst.Block h11: investigation result- the returned nephromax device was analyzed, and a visual evaluation noted that a balloon longitudinal tear beginning approximately 55mm distal of the distal markerband and extending approximately 100mm proximal from the distal markerband.A visual and tactile analysis was performed to the tip and the shaft of the device, and no damages were found.Additionally, a visual examination was performed to the markerbands and no issues were noted.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.With all the available information, boston scientific concludes that the reported event was confirmed.Based on the available information, it is possible that the balloon had an interaction with a stone when the device was being positioned causing a weakness in the balloon material which ruptured and tore, when positive pressure was applied to it.Therefore, the most probable root cause is adverse event related to patient condition.

• Brand Name: NEPHROMAX
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21600580
• Report Number: 2124215-2025-15823
• Device Sequence Number: 8219827
• Product Code: LJE
• UDI-Device Identifier: 08714729826484
• UDI-Public: (01)08714729826484(17)270304(10)33550148
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 04/21/2025

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: M0062101400
• Device Catalogue Number: M0062101400
• Device Lot Number: 0033550148
• 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: 02/12/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2024
• 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