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	03/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the non tortuous iliac artery.A 14-4/5.8/75 xxlballoon catheter was advanced for dilatation.During the procedure, the balloon ruptured at 2 atmospheres.The device was removed immediately without any problem, and the procedure was completed.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
The device was returned for post-use analysis.Upon visual inspection, it was noted that the balloon was not folded, suggesting exposure to positive pressure during use.The presence of blood within the balloon lumen is consistent with a potential leak in the balloon membrane.A subsequent leak test was performed, which identified a pinhole defect located approximately 32 mm distal to the proximal balloon bond.The rated burst pressure for this device is specified as 8 atmospheres, per product specifications.A combined visual and tactile examination of the device shaft revealed no evidence of kinking or structural damage.Additionally, a visual assessment of the distal tip did not reveal any abnormalities or defects.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the non-tortuous iliac artery.A 14-4/5.8/75 xxl balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured at 2 atmospheres.The device was removed immediately without any problem, and the procedure was completed.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: 21830105
• Report Number: 2124215-2025-23046
• Device Sequence Number: 19880021
• Product Code: LIT
• UDI-Device Identifier: 08714729190462
• UDI-Public: (01)08714729190462(17)260801(10)32134475
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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: 08/01/2026
• Device Model Number: M001145140
• Device Catalogue Number: M001145140
• Device Lot Number: 0032134475
• 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: 03/25/2025
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 04/11/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2023
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 93 KG