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

Model Number	M001145140
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon hole occurred.A 14-4/5.8/75 xxl balloon catheter was advanced for dilation.During the procedure, when attempted to inflate the balloon, it did not inflate.The device was removed, and it was noted that there was a hole.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
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.
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.Device evaluated by mfr: the xxl was returned for analysis.The device was received inserted in an introducer sheath.The investigator was unable to remove the device from the introducer sheath.The customers introducer sheath was noted to be accordioned.The device was soaked in a water bath at a temperature of 37 degrees celsius to help soften the solidified blood.The device was removed, and the investigator was able to remove the device from the introducer sheath.The returned device was attached to an encore inflation unit.Positive pressure was applied when di water was observed to be leaking from a balloon pinhole located approximately 12mm proximal from the distal markerband.The investigator was unable to inflate the balloon fully due to the balloon pinhole leak.The rated burst pressure for this device is 8 atmospheres as per xxl specification.A visual and tactile examination identified multiple shaft kinks.A visual examination identified no issues with the tip of the device.This concludes the product analysis.
Event or Problem Description
It was reported that balloon hole occurred.A 14-4/5.8/75 xxl balloon catheter was advanced for dilation.During the procedure, when attempted to inflate the balloon, it did not inflate.The device was removed, and it was noted that there was a hole.The procedure was completed with another of the same device.There were no patient complications as a result of this event.

• 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: 23617170
• Report Number: 2124215-2025-85405
• Device Sequence Number: 9988428
• Product Code: LIT
• UDI-Device Identifier: 08714729190462
• UDI-Public: (01)08714729190462(17)260613(10)31818328
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 01/06/2026

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 Expiration Date: 06/13/2026
• Device Model Number: M001145140
• Device Catalogue Number: M001145140
• Device Lot Number: 0031818328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2023
• 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