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

Model Number	M001145140
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture and tip detachment occurred.The target lesion was located in the vascular artery.A /14-4/5.8/75 xxl balloon catheter was advanced for dilation.During the procedure, the balloon ruptured while being inflated within the nominal to rated pressure range.The balloon was then removed, and it was observed that the tip portion had separated.The procedure was successfully completed using a second device of the same type.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that balloon rupture and tip detachment occurred.The target lesion was located in the vascular artery.A /14-4/5.8/75 xxl balloon catheter was advanced for dilation.During the procedure, the balloon ruptured while being inflated within the nominal to rated pressure range.The balloon was then removed, and it was observed that the tip portion had separated.The procedure was successfully completed using a second device of the same type.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the xxl was returned for analysis.A visual examination identified that the balloon was not folded which indicates that it was subjected to positive pressure.A complete balloon circumferential tear was identified located approximately 720mm distal of the hub.From the complete circumferential tear, the distal section of balloon material was also torn longitudinally.No other issues were noted with the balloon material.As per specification, the rated burst pressure for this device is 8 atmospheres.A visual examination observed no damage to the tip of the device.A visual and tactile examination found two complete separations of the shaft.The first separation is located approximately 715mm distal of the hub.The second separation is located approximately 12mm distal of the first separation.Severe stretching damage was noted to the middle section of shaft.The distal section of shaft includes the distal section of balloon material and the tip of the device.
Additional Manufacturer Narrative
Device evaluated by mfr: the xxl was returned for analysis.A visual examination identified that the balloon was not folded which indicates that it was subjected to positive pressure.A complete balloon circumferential tear was identified located approximately 720mm distal of the hub.From the complete circumferential tear, the distal section of balloon material was also torn longitudinally.No other issues were noted with the balloon material.As per specification, the rated burst pressure for this device is 8 atmospheres.A visual examination observed no damage to the tip of the device.A visual and tactile examination found two complete separations of the shaft.The first separation is located approximately 715mm distal of the hub.The second separation is located approximately 12mm distal of the first separation.Severe stretching damage was noted to the middle section of shaft.The distal section of shaft includes the distal section of balloon material and the tip of the device.
Event or Problem Description
It was reported that balloon rupture and tip detachment occurred.The target lesion was located in the vascular artery.A /14-4/5.8/75 xxl balloon catheter was advanced for dilation.During the procedure, the balloon ruptured while being inflated within the nominal to rated pressure range.The balloon was then removed, and it was observed that the tip portion had separated.The procedure was successfully completed using a second device of the same type.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: 22588858
• Report Number: 2124215-2025-49861
• Device Sequence Number: 13024705
• Product Code: LIT
• UDI-Device Identifier: 08714729190462
• UDI-Public: (01)08714729190462(17)260702(10)31942056
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 12/16/2025

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: 07/02/2026
• Device Model Number: M001145140
• Device Catalogue Number: M001145140
• Device Lot Number: 0031942056
• 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: 06/30/2025
• Supplement Date Received by Manufacturer: 08/29/2025; 11/25/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 09/26/2025; 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2023
• 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: 64 YR
• Patient Sex: Male