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

Model Number M0062101600

Device Problem Burst Container or Vessel (1074)

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

Event Date 08/30/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a nephromax nephrostomy balloon catheter was used int he right kidney during a percutaneous nephrolithonomy (pcnl) procedure performed on (b)(6) 2023.During the procedure, the balloon burst as it was being inflated.The procedure was completed with another nephromax nephrostomy balloon catheter.There were no patient complications reported as a result of this event.

Manufacturer Narrative

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

• Brand Name: NEPHROMAX KIT
• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17765745
• MDR Text Key: 323712197
• Report Number: 3005099803-2023-05021
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 08714729834540
• UDI-Public: 08714729834540
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/18/2023

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: M0062101600
• Device Catalogue Number: 210-160
• Device Lot Number: 0032054535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2023
• 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