MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION XXL ESOPHAGEAL; DILATOR, ESOPHAGEAL

Model Number	23375
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified vessel.A 18-6/5.8/75 xxl balloon catheter was advanced for dilation.During the procedure, the balloon ruptured upon second inflation at 5 atmospheres.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Investigation results: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Risk review: a risk review performed for the xxl device confirmed that the reported event is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefits for the product.Investigation conclusion: this investigation is assigned a conclusion code of cause traced to intentional off-label, unapproved, or contraindicated use because the specified product is an xxl esophageal balloon dilation catheter model which is not indicated for use in the peripheral vasculature such as the venous procedure in the reported event.
Event or Problem Description
It was reported that a balloon rupture occurred.The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified vessel.A 18-6/5.8/75 xxl balloon catheter was advanced for dilation.During the procedure, the balloon ruptured upon second inflation at 5 atmospheres.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications as a result of this event.

• Brand Name: XXL ESOPHAGEAL
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24405203
• Report Number: 2124215-2026-09665
• Device Sequence Number: 9840069
• Product Code: KNQ
• UDI-Device Identifier: 08714729163190
• UDI-Public: (01)08714729163190(17)261115(10)32866902
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

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: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0032866902
• 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: 01/30/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 11/16/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON CATHETER - CHARGER 12X40.; BALLOON CATHETER - CHARGER 12X40.; GUIDEWIRE - AMPLATZ 0.35.; GUIDEWIRE - AMPLATZ 0.35.; STENT - 20X80 WALLSTENTS.; STENT - 20X80 WALLSTENTS.
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Race: White