MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OCCLUDER; CATHETER, UROLOGICAL

Model Number	M0062201070
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a041001 captures the reportable event of balloon hole in material.Block h11: investigation results.The occluder balloon device was returned with stopcock, syringe and part of the box for analysis.A visual evaluation noted that the balloon with a small hole.Microscopic examination was performed under magnification, and it was possible to see that the balloon was with a small torn.Functional examination was performed, and the device was tested with water; however, it did not hold the pressure due to it had a small hole in the balloon.No other problems with the device were noted.With the available information, boston scientific concludes that the reported event of balloon leak was confirmed.Based on the available information it is possible that some manipulation during the procedure could have caused damage on the balloon, and the device had no influence on the event.Additionally, during manufacturing procedure, these devices are visual and functional tested in order to avoid the reported failure.Taking all available information into consideration, the most probable cause of this complaint is adverse event related to procedure because the adverse event occurred during the procedure, and the device had no influence on the event.
Event or Problem Description
It was reported that an occluder balloon catheter was used during a percutaneous nephrolithotomy (pcnl) procedure.During the procedure, the balloon was inflated, and they noticed immediately that there was a leakage from the balloon.The procedure was completed with another of the same device with no patient complications.Analysis of the returned device identified that the balloon was with a small hole.

• Brand Name: OCCLUDER
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22925742
• Report Number: 2124215-2025-59374
• Device Sequence Number: 9107358
• Product Code: EYB
• UDI-Device Identifier: 08714729191988
• UDI-Public: (01)08714729191988(17)260408(10)35007126
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K133750
• 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): 08/29/2025

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: 04/08/2026
• Device Model Number: M0062201070
• Device Catalogue Number: 220-107
• Device Lot Number: 0035007126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• 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