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

Model Number	23375
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon came off the shaft upon removal, stuck in the vein and surgical cut was made to remove the balloon.The 70-90% stenosed and compressed target lesion was located in the non-calcified, so fibrous and some webbing previous deep vein thrombosis (dvt).An 18-4/5.8/75 xxl esophageal balloon catheter was advanced for post dilation after placement of an 22x70 wall stent was placed on the left side.Upon removal, it was noted that the balloon came off the shaft and became stuck in the external iliac vein.A surgical cut down to the left common femoral vein and incision made to the vein to remove the balloon after it was snared.There were no patient complications as a result of this event.Patient went home the next day.
Additional Manufacturer Narrative
H6: impact code added.
Event or Problem Description
It was reported that balloon came off the shaft upon removal, stuck in the vein and surgical cut was made to remove the balloon.The 70-90% stenosed and compressed target lesion was located in the non-calcified, so fibrous and some webbing previous deep vein thrombosis (dvt).An 18-4/5.8/75 xxl esophageal balloon catheter was advanced for post dilation after placement of an 22x70 wall stent was placed on the left side.Upon removal, it was noted that the balloon came off the shaft and became stuck in the external iliac vein.A surgical cut down to the left common femoral vein and incision made to the vein to remove the balloon after it was snared.There were no patient complications as a result of this event.Patient went home the next day.

• 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: 23371097
• Report Number: 2124215-2025-74106
• Device Sequence Number: 15682550
• Product Code: KNQ
• UDI-Device Identifier: 08714729163169
• UDI-Public: (01)08714729163169(17)260808(10)32185023
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 12/05/2025

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 Expiration Date: 08/08/2026
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0032185023
• 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: 09/26/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 12/05/2025
• Date Device Manufactured: 08/09/2023
• 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 Sex: Unknown