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

Model Number	M001145140
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon burst occurred.The 85% stenosed target lesion was located in the mildly tortuous and non-calcified central vein.A 14-4/5.8/75 xxl balloon catheter was advanced for dilation.However, it was noted that the balloon burst during the first inflation before the rated burst pressure.The device was removed, 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
E1 - initial reporter address 1: (b)(6).

• Brand Name: XXL? VASCULAR
• 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: 22935107
• Report Number: 2124215-2025-61221
• Device Sequence Number: 9819674
• Product Code: LIT
• UDI-Device Identifier: 08714729190462
• UDI-Public: (01)08714729190462(17)260625(10)31890977
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K150303
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/01/2025

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: 06/25/2026
• Device Model Number: M001145140
• Device Catalogue Number: M001145140
• Device Lot Number: 0031890977
• 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: 08/11/2025
• Initial Report FDA Received Date: 09/02/2025
• Date Device Manufactured: 06/26/2023
• 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 Sex: Unknown