MAUDE Adverse Event Report: FUTUREMATRIX INTERVENTIONAL INC. PCNL BALLOON, 10MM(30FR) X15CM

Model Number	BPCN1015
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported the subject device pressured up to 17 ppr and the balloon burst.The issue occurred during a percutaneous nephrolithotomy under sedation with a delay of less than thirty minutes.The procedure was completed with an olympus back-up device.There were no reports of patient harm.This is report 2 of 2.
Event or Problem Description
No additional information received from the customer.
Additional Manufacturer Narrative
The mdr supplemental report is being submitted to provide updated fields and final investigation results.Updated fields: d8, h2, h3, h6, h11.The device was returned for evaluation and the customer's allegation was confirmed.A definitive root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: cause not established.Olympus will continue to monitor the performance of this device.

• Brand Name: PCNL BALLOON, 10MM(30FR) X15CM
• Common Device Name: PCNL BALLOON, 10MM(30FR) X15CM
• Manufacturer (Section D): FUTUREMATRIX INTERVENTIONAL INC.; 1605 enterprise street; athens TX 75751
• Manufacturer (Section G): FUTUREMATRIX INTERVENTIONAL INC.; 1605 enterprise street; athens TX 75751
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 22021683
• Report Number: 3011050570-2025-00486
• Device Sequence Number: 18524262
• Product Code: LJE
• UDI-Device Identifier: 00821925033023
• UDI-Public: 00821925033023
• Combination Product (Y/N): N
• Initial Reporter State: OH
• PMA/510(K) Number: K132383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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 Model Number: BPCN1015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BPCN1015K
• Patient Sex: Unknown