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

Model Number	M001145320
Medical Device Problem Code	Fluid/Blood Leak (1250)
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 the balloon leak occurred.The 90% stenosed target lesion was located in the left iliac vein.During the procedure, routine left femoral vein puncture with a 10f sheath was performed.The guidewire and catheter were advanced through the stenotic segment of the left iliac vein, and the guidewire entered the inferior vena cava.A /14-6/5.8/75 xxl was flushed and delivered into the body.However, upon balloon dilatation using a pressured pump, a contrast extravasation was noted.Upon withdrawal, it was noted that the balloon was leaking liquid, and it could not be used.The procedure was completed using a xxl 14 * 60 balloon catheter.There were no complications as a result of this event, and the patient was stable post-procedure.However, device analysis revealed a longitudinal tear identified in the balloon material.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).E1: initial reporter phone: (b)(6).Device evaluated by mfr: the xxl device was returned to our post market quality assurance laboratory.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured 20mm in length and extended from a position approximately 6mm proximal of the proximal markerband to 14mm distal of the proximal markerband.An examination of the tip of the device identified no issues.The rated burst pressure for this device is 8 atmospheres as per xxl specification.A visual and tactile examination identified no issues with the shaft and tip of the device.This concludes the product analysis.

• 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 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23678632
• Report Number: 2124215-2025-87834
• Device Sequence Number: 15681118
• Product Code: LIT
• UDI-Device Identifier: 08714729190486
• UDI-Public: (01)08714729190486(17)260504(10)31559001
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/01/2025

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: 05/04/2026
• Device Model Number: M001145320
• Device Catalogue Number: M001145320
• Device Lot Number: 0031559001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2023
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 70 KG