MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EQUALIZER?; CATHETER, PERCUTANEOUS

Model Number	M001171090
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.An equalizer balloon catheter was selected for use during an aortic stent graft placement procedure.During the procedure, the balloon ruptured.Two additional balloons were used which resulted in extended procedure time.The procedure was completed.
Additional Manufacturer Narrative
B3 - date of event: event date was not provided and estimated based on aware date.Additional event and patient details were not provided to bsc.We completed a good faith effort to obtain the information, but it was unable to be obtained.If additional details become available, a supplemental report will be submitted.

• Brand Name: EQUALIZER?
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23594895
• Report Number: 2124215-2025-83061
• Device Sequence Number: 15847477
• Product Code: MJN
• UDI-Device Identifier: 08714729402398
• UDI-Public: (01)08714729402398(17)260318(10)34855024
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140273
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2025

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: 03/18/2026
• Device Model Number: M001171090
• Device Catalogue Number: M001171090
• Device Lot Number: 0034855024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 11/19/2025
• Date Device Manufactured: 09/16/2024
• 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