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

Model Number	M0062101420
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable event of ro marker detached.
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 radiopaque marker on the clear renal sheath came off of the sheath after it was inflated.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 radiopaque marker on the clear renal sheath was detached inside the patient through the renal facia after it was inflated.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block h2: additional information: block b1, block b5 (describe event or problem), block h6 and block h1.Block h6: device code a0501 captures the reportable event of ro marker detached.Block h6: patient code e2008 captures the reportable event of foreign body in patient.Block h11: investigation results the returned nephromax balloon catheter was analyzed, and a visual evaluation noted that the balloon was not folded, indicating that the balloon was subjected to positive pressure.No issues were found with the balloon of the device.The renal sheath was not returned for analysis.A visual and tactile examination were performed to the shaft, and no kinks or damage were found.There were no issues found in the markerband and tip of the device.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 not confirmed.Based on analysis results, it is possible that the sheath was damaged due to handling during preparation for the procedure, but this cannot be confirmed.Therefore, cause not established is selected as the most probable cause for the complaint.

• 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: 21509977
• Report Number: 2124215-2025-12469
• Device Sequence Number: 19945754
• Product Code: LJE
• UDI-Device Identifier: 08714729826491
• UDI-Public: 08714729826491
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 03/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0062101420
• Device Catalogue Number: M0062101420
• Device Lot Number: 0033401048
• 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: 02/10/2025
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown