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

Model Number	23375
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture and removal difficulties occurred resulting to a surgical intervention.The target lesion was located in a fistula.A 14-6/5.8/75 xxl vascular balloon catheter was advanced for dilatation.However, during inflation at 8 atmospheres, the balloon ruptured.The balloon was stuck in the vessel and could not be removed.The patient was sent for an open surgery to remove the balloon.No further patient complications were reported.
Event or Problem Description
It was reported that balloon rupture and removal difficulties occurred resulting to a surgical intervention.The target lesion was located in a fistula.A 14-6/5.8/75 xxl vascular balloon catheter was advanced for dilatation.However, during inflation at 8 atmospheres, the balloon ruptured.The balloon was stuck in the vessel and could not be removed.The patient was sent for an open surgery to remove the balloon.No further patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: a xxl device was received for analysis.A visual examination identified that the device was received with the balloon, markerbands, tip and part of shaft detached.A visual and tactile examination identified multiple shaft kinks.The tip region was detached and not returned with the device.

• Brand Name: XXL VASCULAR
• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15698280
• Report Number: 2124215-2022-40474
• Device Sequence Number: 5578481
• Product Code: LIT
• UDI-Device Identifier: 08714729190486
• UDI-Public: 08714729190486
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K150303
• 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): 12/14/2022

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: 08/07/2025
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0029907788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2022
• Supplement Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown