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

Model Number	M001145540
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial facility reporter name: (b)(6) hospital.
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the iliac vein.A 16-6/5.8/75 xxl balloon catheter was advanced for dilation.During the procedure, the balloon was unpacked and was dilated with a pressure pump.It was found that the anterior segment of the balloon was leaked gas and liquid.It was also observed that the balloon ruptured upon second inflation at 5 atmospheres for 60 seconds.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1: initial facility reporter name: (b)(6).Device evaluated by mfr: the xxl was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The balloon was attached to an encore inflation device, subjected to positive pressure and di water was observed to be leaking from a balloon pinhole located 13mm distal from the distal markerband.The rated burst pressure for this device is 5 atmospheres as per xxl specification.A visual and tactile examination identified no kinks or damage to the shaft.A visual examination identified no issues with the tip of the device.
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the iliac vein.A 16-6/5.8/75 xxl balloon catheter was advanced for dilation.During the procedure, the balloon was unpacked and was dilated with a pressure pump.It was found that the anterior segment of the balloon was leaked gas and liquid.It was also observed that the balloon ruptured upon second inflation at 5 atmospheres for 60 seconds.The procedure was completed with another of the same device.There were no patient complications as a result of this event.

• 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: 22215932
• Report Number: 2124215-2025-39574
• Device Sequence Number: 8157864
• Product Code: KNQ
• UDI-Device Identifier: 08714729163114
• UDI-Public: (01)08714729163114(17)250504(10)29341480
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 07/21/2025

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: 05/04/2025
• Device Model Number: M001145540
• Device Catalogue Number: M001145540
• Device Lot Number: 0029341480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2022
• 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: 55 YR
• Patient Sex: Male