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

Model Number	M001171100
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Ischemia (1942); Embolism/Embolus (4438)
Date of Event	03/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Good faith effort attempts were made to retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that the balloon mobilized, and patient complications occurred.A 33mm 100cm equalizer balloon was selected for an organ procurement.After inflation of the balloon in the descending thoracic aorta, the cardiopulmonary bypass (cpb) decreased.The balloon mobilized spontaneously and rose to the ascending aorta.Consequently, the procedure was stopped.It was reported that loss of liver and kidney grafts occurred.
Additional Manufacturer Narrative
H6: patient codes (1): updated from ischemia to embolism/embolus.Good faith effort attempts were made to retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that the balloon mobilized, and patient complications occurred.A 33mm 100cm equalizer balloon was selected for an organ procurement.After inflation of the balloon in the descending thoracic aorta, the cardiopulmonary bypass (cpb) decreased.The balloon mobilized spontaneously and rose to the ascending aorta.Consequently, the procedure was stopped.It was reported that loss of liver and kidney grafts occurred.

• 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: 22096000
• Report Number: 2124215-2025-33458
• Device Sequence Number: 8059981
• Product Code: MJN
• UDI-Device Identifier: 08714729402404
• UDI-Public: (01)08714729402404(17)260424(10)35127151
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/24/2026
• Device Model Number: M001171100
• Device Catalogue Number: M001171100
• Device Lot Number: 0035127151
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 02/04/2026
• Date Device Manufactured: 10/23/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown