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

Model Number	M0062101620
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a0402 captures the reportable event of balloon burst.Block h11: investigation result the product was not returned for analysis and was discarded at the facility.As per specification the rated burst pressure of this device was 20 atmospheres; however, based on the device being used during a percutaneous nephrolithotomy (pcnl) procedure to treat a kidney stone.It is most probable that the device had an interaction with a stone which would have contributed to the balloon rupture.Therefore, the most probable root cause is adverse event related to patient condition.
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, the physician was trying to inflate the balloon and noticed under flouro that the balloon was not taking shape.Reportedly, upon deflating and pulling out the balloon it burst.They tried re-inflating the balloon, but it was not possible.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 product was not returned for analysis and was discarded at the facility.As per specification the rated burst pressure of this device was 20 atmospheres; however, based on the device being used during a percutaneous nephrolithotomy (pcnl) procedure to treat a kidney stone.It is most probable that the device had an interaction with a stone which would have contributed to the balloon rupture.Therefore, the most probable root cause is adverse event related to patient condition.
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, the physician was trying to inflate the balloon and noticed under flouro that the balloon was not taking shape.Reportedly, upon deflating and pulling out the balloon it burst, and the pressure was at 20 atmospheres (atm).They tried re-inflating the balloon, but it was not possible.The procedure was completed with another of the same device with no patient complications.

• 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; ballybrit business park; galway ; EI
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21107952
• Report Number: 2124215-2024-82910
• Device Sequence Number: 8153795
• Product Code: LJE
• UDI-Device Identifier: 08714729834526
• UDI-Public: 08714729834526
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 01/27/2025

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: M0062101620
• Device Catalogue Number: M0062101620
• Device Lot Number: 0035112494
• 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: 12/11/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 01/27/2025
• Date Device Manufactured: 02/15/2024
• 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