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

Model Number	M0062101170
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable event of torn material.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax nephrostomy balloon catheter was used during a percutaneous nephrolithonomy (pcnl) procedure performed on august 31, 2023.During the procedure, the nephromax balloon was torn was soon as it was inflated.The procedure was completed with another nephromax nephrostomy balloon catheter.No patient complications have reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable event of torn material.Block h2: additional information: block d4 (lot number) have been updated based on the additional information received on (b)(6) 2023.Block h10: investigation result a visual examination of the returned complaint device found that the balloon had a longitudinal tear beginning approximately 5mm proximal of the distal markerband and extending approximately 12mm proximal from the distal markerband.A visual and tactile examination revealed no issues or damage with the tip and the shaft.Additionally, there was no issues noted with the markerband.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.Based on the available information, there was no evidence of a manufacturing or design issue which could have caused the complaint and there is no evidence that the device failed to meet nephromax ng specification prior to shipping.Additional information was requested with regards to patient anatomy and lesion characteristics; however, this information was not available.It is possible that difficult patient anatomy contributed to the longitudinal tear in the balloon material.This device was used during a percutaneous nephrolithotripsy (pnl) procedure, which is a procedure to treat kidney stones of the nephrostomy tract.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 procedure.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax nephrostomy balloon catheter was used during a percutaneous nephrolithonomy (pcnl) procedure performed on (b)(6) 2023.During the procedure, the nephromax balloon was torn as soon as it was inflated.The procedure was completed with another nephromax nephrostomy balloon catheter.No patient complications have been 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 5086834015
• MDR Report Key: 18204793
• Report Number: 2124215-2023-65224
• Device Sequence Number: 7373217
• Product Code: LJE
• UDI-Device Identifier: 08714729012641
• UDI-Public: 08714729012641
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2023

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: 08/01/2025
• Device Model Number: M0062101170
• Device Catalogue Number: 210-117
• Device Lot Number: 0029875479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2023
• Supplement Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 11/24/2023
• Supplement Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2022
• 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