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

Model Number	M0062101180
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a percutaneous nephrolithotomy procedure with this nephromax nephrostomy balloon catheter, the device was weak at maximum inflation and it ruptured; additioanlly, it was said that there was a bleeding as cause of this event.No further information was reported and there were no additional patient complications reported.
Additional Manufacturer Narrative
Block b3: date of event was approximated to 04/01/2024 based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Block h6: imdrf device code a0402 captures the reportable event of balloon burst.
Additional Manufacturer Narrative
B3: event date.B5: type of procedure.D4: lot number, expiration date.Block h6: imdrf device code a0402 captures the reportable event of balloon burst.Imdrf evaluation conclusion code d1001 has been added.
Event or Problem Description
It was reported that during a percutaneous nephrolithotomy procedure with this nephromax nephrostomy balloon catheter, the device was weak at maximum inflation and it ruptured; additionally, it was said that there was a bleeding as cause of this event.No further information was reported and there were no additional patient complications reported.

• 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: 19337529
• Report Number: 2124215-2024-30001
• Device Sequence Number: 2582190
• Product Code: LJE
• UDI-Device Identifier: 08714729077589
• UDI-Public: 08714729077589
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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): 06/10/2024

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: 07/11/2025
• Device Model Number: M0062101180
• Device Catalogue Number: 210-118
• Device Lot Number: 0031104002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2024
• Supplement Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2022
• 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