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 Consequences Or Impact To Patient (2199)
Date of Event	07/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the aortic arch.A 16-4/5.8/120 xxl esophageal balloon was advanced for dilation.However, when the balloon was removed from the patient's body, it was not intact and noted to be ruptured during the case.No patient complications nor injuries reported and the patient's status was good.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the aortic arch.A 16-4/5.8/120 xxl esophageal balloon was advanced for dilation.However, when the balloon was removed from the patient's body, it was not intact and noted to be ruptured during the case.No patient complications nor injuries reported and the patient's status was good.It was further reported that the more than 50% stenosed target lesion was located in the non-tortuous and mildy calcified aortic arch.The balloon ruptured on the third inflation at 5 atmospheres for 10 to 15 seconds.The device was smoothly removed from the patient's body.

• 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: 10280548
• Report Number: 2134265-2020-09418
• Device Sequence Number: 14109495
• Product Code: KNQ
• UDI-Device Identifier: 08714729163084
• UDI-Public: 08714729163084
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2020

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: 03/19/2021
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0021883228
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 07/19/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 08/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR