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

Model Number	M001145320
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.Patient was presented with may thurner's.The 80% stenosed target lesion was located in the mildly tortuous and non-calcified common iliac artery.After gaining popliteal access with a 9fr sheath, an amplatz wire was advanced followed by placing a non-boston scientific stent.A 14-6/5.8/75 xxl vascular was advanced for dilation.During first inflation at 5 atmospheres for 1 second, the balloon burst.The device was removed intact, 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
Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified inside the balloon which is evidence of a device leak.A balloon longitudinal tear was identified beginning approximately 33mm proximal of the tip bond and extending approximately 5mm proximally across the balloon material.The rated burst pressure for this device is 8 atmospheres as per xxl specification.A visual and tactile examination identified no kinks or damage to the shaft of the device.A visual examination identified no issues with the tip of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.Patient was presented with may thurner's.The 80% stenosed target lesion was located in the mildly tortuous and non-calcified common iliac artery.After gaining popliteal access with a 9fr sheath, an amplatz wire was advanced followed by placing a non-boston scientific stent.A 14-6/5.8/75 xxl vascular was advanced for dilation.During first inflation at 5 atmospheres for 1 second, the balloon burst.The device was removed intact, and 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: 21850221
• Report Number: 2124215-2025-23850
• Device Sequence Number: 7851710
• Product Code: LIT
• UDI-Device Identifier: 08714729190486
• UDI-Public: (01)08714729190486(17)260823(10)32285855
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 08/23/2026
• Device Model Number: M001145320
• Device Catalogue Number: M001145320
• Device Lot Number: 0032285855
• 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: 04/01/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 04/16/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2023
• 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 Sex: Unknown