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

Model Number	M0062101170
Medical Device Problem Codes	Inflation Problem (1310); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a nephromax high pressure nephrostomy balloon catheter was used in the right kidney during a percutaneous nephrolithotomy (pnl) procedure performed on (b)(6) 2022.During the procedure, the balloon would not inflate above 8 atm.The device was then removed, and the procedure was completed with another nephromax high pressure nephrostomy balloon catheter.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of balloon pinhole.
Additional Manufacturer Narrative
(b)(4).Investigation result: a visual examination of the returned nephromax balloon was analyzed, and a visual evaluation noted that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Functional evaluation was performed by attaching the device into an encore inflation unit, and it was found that the balloon had a pinhole leak located at the proximal of the distal markerband.A visual and tactile analysis revealed that there were no problems found to the shaft, markerbands and the tip of the device.The reported event of balloon would not inflate was confirmed.It is possible that the interaction between the device and the kidney stone could have affected the device performance and its integrity, leading to the presence of a pinhole in the balloon material.Therefore, the most probable cause of the reported event is adverse event related to patient condition.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.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15769888
• Report Number: 3005099803-2022-06363
• Device Sequence Number: 20460219
• Product Code: LJE
• UDI-Device Identifier: 08714729012641
• UDI-Public: 08714729012641
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/10/2022

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: 02/18/2023
• Device Model Number: M0062101170
• Device Catalogue Number: 210-117
• Device Lot Number: 0025229650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2020
• 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 Age: 64 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Race: White