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

Model Number	M0062101600
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation result a visual examination of the returned complaint device found that the balloon was torn longitudinally from the distal of the distal markerband extending across the proximal from the distal markerband.A visual and tactile analysis were performed and revealed that there was no problem found to the tip and shaft of the catheter.Additionally, no problem was observed on the markerbands.It is possible that the difficult patient anatomy, and the interaction between the balloon and the kidney stone while the device was being positioned caused weakness to the balloon material when positive pressure was applied, leading to balloon bursting and the found problem of balloon torn longitudinally.Additionally, with the balloon being torn longitudinally, an optimum balloon refold could have been compromised and the balloon would unable to inflate.With a compromised balloon refold the device could have encountered resistance advancing through the sheath.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 instruction for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax nephrostomy balloon catheter was used in the kidney during a percutaneous nephrolithonomy (pcnl) procedure performed on (b)(6) 2021.During the procedure, it was noticed that there was a narrow spot in the balloon and the renal sheath did not cross well.The procedure was completed with another nephromax 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 torn longitudinally.

• 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: 13652909
• Report Number: 3005099803-2022-01050
• Device Sequence Number: 14073833
• Product Code: LJE
• UDI-Device Identifier: 08714729834540
• UDI-Public: 08714729834540
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/02/2022

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: 06/13/2024
• Device Model Number: M0062101600
• Device Catalogue Number: 210-160
• Device Lot Number: 0027915857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2021
• 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