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

Model Number M0062101400

Device Problem Burst Container or Vessel (1074)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0402 captures the reportable event of balloon burst.

Event Description

It was reported to boston scientific corporation that a nephromax nephrostomy balloon catheter device was used during a ureteroscopy (urs) procedure performed on (b)(6) 2023.During the procedure, the balloon pop when rising the pressure to 12 atm (atmosphere).The procedure was completed with another nephromax nephrostomy balloon catheter device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be good.

Manufacturer Narrative

Block h2: additional information: block d4 (lot number) have been updated based on the additional information received on november 9, 2023.Block h6: imdrf device code a0402 captures the reportable event of balloon burst.Block h10: investigation result.A visual examination of the returned device found a longitudinal tear on the balloon measuring approximately 25mm in length located in the proximal region of the balloon.A visual and tactile examination was performed to the tip, catheter shaft and the markerband, and no damages were found.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.As this device is recommended for dilatation of the nephrostomy tract, and was used during a ureteroscopy procedure, it is possible that the balloon had an interaction with a stone which would have contributed to the rupture in the balloon material.Therefore, the most probable root cause is adverse event related to procedure.

Event Description

It was reported to boston scientific corporation that a nephromax nephrostomy balloon catheter device was used during a ureteroscopy (urs) procedure performed on (b)(6) 2023.During the procedure, the balloon pop when rising the pressure to 12 atm (atmosphere).The procedure was completed with another nephromax nephrostomy balloon catheter device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be good.

• Brand Name: NEPHROMAX
• Type of Device: 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: 18097849
• MDR Text Key: 327714994
• Report Number: 2124215-2023-62038
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 08714729826484
• UDI-Public: 08714729826484
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K121614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2023

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
• Device Operator: Health Professional
• Device Model Number: M0062101400
• Device Catalogue Number: 210-140
• Device Lot Number: 0030412928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2023
• Initial Date FDA Received: 11/08/2023
• Supplement Dates Manufacturer Received: 11/09/2023
• Supplement Dates FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male