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

Model Number	M0062101170
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf 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 nephrolithonomy (pcnl) procedure.During the procedure, the physician inserted a nephromax balloon catheter and pumped saline with an encore high pressure inflation at 12 atm; however, the balloon ruptured and leaked inside the patient.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf 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 5mm distal of the distal markerband and extending approximately 18mm 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.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.
Event or Problem Description
It was reported that a nephromax nephrostomy balloon catheter was used during a percutaneous nephrolithonomy (pcnl) procedure.During the procedure, the physician inserted a nephromax balloon catheter and pumped saline with an encore high pressure inflation at 12 atm; however, the balloon ruptured and leaked inside the patient.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

• 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: 19400886
• Report Number: 2124215-2024-32018
• Device Sequence Number: 15552162
• Product Code: LJE
• UDI-Device Identifier: 08714729012641
• UDI-Public: 08714729012641
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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 Expiration Date: 05/31/2024
• Device Model Number: M0062101170
• Device Catalogue Number: 210-117
• Device Lot Number: 0027416207
• 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: 05/09/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 05/27/2024
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2021
• 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: Male