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

Model Number	M0062101180
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation result: the returned nephromax balloon device was analyzed, and a visual evaluation noted that the balloon was not folded which indicates that the device was subjected to positive pressure.It was also observed that the balloon was torn longitudinally from the proximal of the distal markerband extending proximal of the distal markerband.No problems were identified to the balloon material and markerbands.A visual and tactile examinations revealed that there were no problems found to the tip and the shaft of the device.The reported event was confirmed.It is possible that the device had interaction with a stone, leading to the found problem of balloon torn longitudinally.Therefore, the most probable root cause is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on event.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.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax balloon kit was used during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2022.During the procedure, it was noticed that the balloon was pierced and could not be used in a procedure.The procedure was completed with another nephromax balloon kit.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 torn longitudinally.Please see block for full investigation details.

• Brand Name: NEPHROMAX KIT
• 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: 14159597
• Report Number: 3005099803-2022-01843
• Device Sequence Number: 2943743
• Product Code: LJE
• UDI-Device Identifier: 08714729077589
• UDI-Public: 08714729077589
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2022

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: 04/19/2024
• Device Model Number: M0062101180
• Device Catalogue Number: 210-118
• Device Lot Number: 0027540078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2021
• 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