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	01/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 58% stenosed target lesion was located in the mild to moderately tortuous iliac vein.A 16-6/5.8/75 xxl esophageal balloon catheter was advanced for dilatation.However, during the fourth inflation at 5 atmospheres for 5-10 seconds, the balloon ruptured.The device was removed and the procedure was completed with a 16x6 xxl balloon catheter.There were no complications nor injuries reported.
Event or Problem Description
It was reported that balloon rupture occurred.The 58% stenosed target lesion was located in the mild to moderately tortuous iliac vein.A 16-6/5.8/75 xxl esophageal balloon catheter was advanced for dilatation.However, during the fourth inflation at 5 atmospheres for 5-10 seconds, the balloon ruptured.The device was removed and the procedure was completed with a 16x6 xxl balloon catheter.There were no complications nor injuries reported.

• Brand Name: XXL ESOPHAGEAL
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13500405
• Report Number: 2134265-2022-01325
• Device Sequence Number: 5304202
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/09/2022

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: 11/02/2024
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0028321392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2021
• 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