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

Model Number	M001145520
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that a balloon rupture occurred.A16-4/5.8/75 xxl esophageal balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured at low inflation pressures.The procedure was completed with a 14 mm xxl balloon catheter.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that a balloon rupture occurred.A16-4/5.8/75 xxl esophageal balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured at low inflation pressures.The procedure was completed with a 14 mm xxl balloon catheter.There were no patient complications as a result of this event.It was further reported that the 70% stenosed target lesion was located in non-tortuous and non-calcified bilateral iliac veins.During the second inflation at or below nominal pressure, the balloon ruptured.It was determined that patient anatomy did not contribute to the reported event.Additionally, patient factors and procedural factors were not found to have contributed to the incident.
Additional Manufacturer Narrative
B5 - describe event or problem: updated to include new information obtained.
Event or Problem Description
It was reported that a balloon rupture occurred.A16-4/5.8/75 xxl esophageal balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured at low inflation pressures.The procedure was completed with a 14 mm xxl balloon catheter.There were no patient complications as a result of this event.It was further reported that the 70% stenosed target lesion was located in non-tortuous and non-calcified bilateral iliac veins.During the second inflation at or below nominal pressure, the balloon ruptured.It was determined that patient anatomy did not contribute to the reported event.Additionally, patient factors and procedural factors were not found to have contributed to the incident.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23868066
• Report Number: 2124215-2025-92380
• Device Sequence Number: 4451472
• Product Code: KNQ
• UDI-Device Identifier: 08714729163060
• UDI-Public: (01)08714729163060(17)261023(10)32704178
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 03/02/2026

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: M001145520
• Device Catalogue Number: M001145520
• Device Lot Number: 0032704178
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 01/09/2026; 02/12/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 01/22/2026; 03/02/2026
• Date Device Manufactured: 10/24/2023
• 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
• Patient Age: 33 YR
• Patient Sex: Female