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

Model Number	23375
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred requiring a cut down for removal.The 50-60% stenosed target lesion was located in the mildly tortuous external iliac vein.An xxl/18-4/5.8/75 balloon catheter was advanced for dilation.However, during the procedure, it was noted that the catheter shaft broke off inside the patient, requiring a cut down to remove the broken piece.There were no device fragments left inside the patient's body.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient is expected to fully recover.
Event or Problem Description
It was reported that shaft break occurred requiring a cut down for removal.The 50-60% stenosed target lesion was located in the mildly tortuous external iliac vein.An xxl/18-4/5.8/75 balloon catheter was advanced for dilation.However, during the procedure, it was noted that the catheter shaft broke off inside the patient, requiring a cut down to remove the broken piece.There were no device fragments left inside the patient's body.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient is expected to fully recover.It was further reported that the device broke during the procedure which caused the part that broke off to be stuck with no way to retrieve except cut down.
Additional Manufacturer Narrative
Updated h6: evaluation conclusion codes.B5.Describe event or problem: added information, based on additional information.

• Brand Name: XXL ESOPHAGEAL
• 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: 23733001
• Report Number: 2124215-2025-87371
• Device Sequence Number: 18600540
• Product Code: KNQ
• UDI-Device Identifier: 08714729163169
• UDI-Public: (01)08714729163169(17)261025(10)32722847
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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): 12/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0032722847
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 12/16/2025
• Date Device Manufactured: 10/26/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Race: Black Or African American