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	08/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon migrated, and patient complications occurred.A 33mm 100cm equalizer balloon was selected for an organ procurement.The device was positioned at the level of the supra-diaphragmatic abdominal aorta.The device migrated to the level of the thoracic aorta, then to the left ventricle.Consequently, the procedure was stopped.It was reported that loss of liver and kidney grafts occurred.
Additional Manufacturer Narrative
Good faith effort attempts were made to retrieve additional details regarding the reported event and the device status, but further information was unable to be obtained.The lot number was not provided to boston scientific (bsc).We completed a good faith effort to obtain the information, but it was unable to be obtained.Because the lot number is unknown, we are unable to provide the full unique identifier (udi) # and other specific product information.
Event or Problem Description
It was reported that the balloon migrated, and patient complications occurred.A 33mm 100cm equalizer balloon was selected for an organ procurement.The device was positioned at the level of the supra-diaphragmatic abdominal aorta.The device migrated to the level of the thoracic aorta, then to the left ventricle.Consequently, the procedure was stopped.It was reported that loss of liver and kidney grafts occurred.
Additional Manufacturer Narrative
D4: lot number, expiration date updated.D9: device avail for evaluation?, returned to manufacturer date updated.H4: device manufacture date updated.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 migrated, and patient complications occurred.A 33mm 100cm equalizer balloon was selected for an organ procurement.The device was positioned at the level of the supra-diaphragmatic abdominal aorta.The device migrated to the level of the thoracic aorta, then to the left ventricle.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.Device evaluated by mfr: the device was returned for analysis, however no damages were observed in the equalizer.Good faith effort attempts were made to retrieve additional details regarding the reported event, but further information was unable to be obtained.

• 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: 23490812
• Report Number: 2124215-2025-78841
• Device Sequence Number: 17301288
• Product Code: MJN
• UDI-Device Identifier: 08714729402404
• UDI-Public: (01)08714729402404(17)260731(10)35737440
• 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,Followup,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: 07/31/2026
• Device Model Number: M001171100
• Device Catalogue Number: M001171100
• Device Lot Number: 0035737440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: 12/03/2025; 01/06/2026
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 12/22/2025; 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2025
• 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