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

Model Number M0062101170

Device Problems Inflation Problem (1310); Material Deformation (2976)

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

Event Date 07/18/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a nephromax nephrostomy balloon was used during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6), 2023.During the procedure, the balloon continues to "waste" and would not fully inflate even when inflated to the maximum pressure.The balloon was removed and was attempted to inflate again multiple times after slightly repositioning the wire but sill unsuccessful.After inspection, it was noticed that there was a kink in the balloon which was causing the balloon from fully inflating.The procedure was completed with another nephromax nephrostomy balloon.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Section e: this event was reported by the bsc sales representative.The health care facility is: (b)(6) phone: (b)(6) block h6: imdrf device code a0406 captures the reportable event of balloon irregular shape.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17546135
• MDR Text Key: 321117544
• Report Number: 3005099803-2023-04309
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 08714729012641
• UDI-Public: 08714729012641
• 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: Other
• Type of Report: Initial
• Report Date: 08/14/2023

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: M0062101170
• Device Catalogue Number: 210-117
• Device Lot Number: 0030025641
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/18/2023
• Initial Date FDA Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1