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

Model Number	23375
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 85% stenosed target lesion was located in the mild to moderately tortuous right iliac vein.A 16-6/5.8/75 xxl esophageal balloon catheter was advanced to pre-dilate the vessel.The balloon was inflated in three different areas at 5 atmospheres (atm) and a wallstent was successfully deployed.The same balloon was inserted to post dilate the stent to get better wall apposition; however, on the fourth inflation at 4 atm for 10 seconds, the balloon ruptured.The balloon was fully deflated and removed from the patient fully intact.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: XXL ESOPHAGEAL
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12697083
• Report Number: 2134265-2021-13400
• Device Sequence Number: 4444445
• Product Code: KNQ
• UDI-Device Identifier: 08714729163114
• UDI-Public: 08714729163114
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/26/2021

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: 08/05/2024
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0027793470
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1