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

Model Number	M001145140
Medical Device Problem Codes	Difficult to Remove (1528); 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	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon burst and became entangled with the tip of the sheath.A 14-4/5.8/75 xxl balloon catheter was used to treat stenosis of the central vein identified after arteriovenous fistula percutaneous transluminal angioplasty (avf pta) procedure.However, after positioning the product on the lesion and increasing pressure to the nominal level, the balloon burst, causing contrast agent leakage.During withdrawal, the balloon became entangled with the tip of the sheath and was unable to be removed.As a result, the catheter was cut and removed along with the sheath.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient was in good condition after the procedure.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).Device evaluated by mfr: the xxl was returned for evaluation.A visual and tactile examination identified a shaft separation located approximately 40mm proximal of the proximal balloon sleeve.The separation displays evidence of the shaft having been cut with a sharp implement.Multiple shaft kinks was also noted along the length of the device.The recommended sheath size as per xxl specification for this device is a minimum 7fr.The investigator was unable to advance the device through the 7fr boston scientific introducer sheath due to the shaft break and shaft kinks.A visual and tactile examination identified that the balloon was not tightly folded and had been subject to positive pressure.The investigator was able to inflate the balloon using a syringe and a pinhole in the balloon material was identified located approximately 12mm distal of the proximal balloon sleeve.A visual examination identified no issues with the tip of the device.
Event or Problem Description
It was reported that the balloon burst and became entangled with the tip of the sheath.A 14-4/5.8/75 xxl balloon catheter was used to treat stenosis of the central vein identified after arteriovenous fistula percutaneous transluminal angioplasty (avf pta) procedure.However, after positioning the product on the lesion and increasing pressure to the nominal level, the balloon burst, causing contrast agent leakage.During withdrawal, the balloon became entangled with the tip of the sheath and was unable to be removed.As a result, the catheter was cut and removed along with the sheath.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient was in good condition after the procedure.

• 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: 23536556
• Report Number: 2124215-2025-81060
• Device Sequence Number: 10202582
• Product Code: LIT
• UDI-Device Identifier: 08714729190462
• UDI-Public: (01)08714729190462(17)260622(10)31882886
• 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
• Report Date (Section B): 01/20/2026

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: 06/22/2026
• Device Model Number: M001145140
• Device Catalogue Number: M001145140
• Device Lot Number: 0031882886
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2023
• 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