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

Model Number	M0062101640
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax nephrostomy balloon catheter was used in the kidney during a percutaneous nephrolithonomy (pcnl) procedure performed on (b)(6) 2023.During the procedure, the balloon burst at 18 (atm) atmospheric pressure.The procedure was completed with another nephromax nephrostomy balloon catheter.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax nephrostomy balloon catheter was used in the kidney during a percutaneous nephrolithonomy (pcnl) procedure performed on (b)(6) 2023.During the procedure, the balloon burst at 18 (atm) atmospheric pressure.The procedure was completed with another nephromax nephrostomy balloon catheter.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Block e1 (initial reporter title, initial reporter first name, initial reporter last name, initial reporter facility name, initial reporter address 1, initial reporter city, initial reporter state, initial reporter zip/post code, initial reporter phone) updated block e2 health professional updated block e3 occupation updated block h6: imdrf device code a0402 captures the reportable event of balloon burst.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18427605
• Report Number: 2124215-2023-74131
• Device Sequence Number: 7697290
• Product Code: LJE
• UDI-Device Identifier: 08714729834533
• UDI-Public: 08714729834533
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 01/19/2024

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 Model Number: M0062101640
• Device Catalogue Number: 210-164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2023
• Supplement Date Received by Manufacturer: 12/31/2023
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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