MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION XXL VASCULAR; 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	06/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 14-2/5.8/75 xxl balloon catheter was advanced for dilatation.However, during the inflation, the balloon ruptured inside the artery.There were no patient complications reported.
Additional Manufacturer Narrative
Device was returned to the manufacturer: the xxl balloon dilator was received and underwent a visual examination.It was identified that the balloon was not folded which indicates that the device was subjected to positive pressure.A longitudinal tear in the balloon material was discovered.No damage or issues were noted with the markerbands, tip or shaft of the device.No other issues confirmed.This concludes the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.A 14-2/5.8/75 xxl balloon dilator was advanced for dilatation.However, during the inflation, the balloon ruptured inside the artery.There were no patient complications reported.

• Brand Name: XXL VASCULAR
• 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: 17379164
• Report Number: 2124215-2023-37340
• Device Sequence Number: 6399335
• Product Code: LIT
• UDI-Device Identifier: 08714729162926
• UDI-Public: 08714729162926
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2024

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: 01/10/2026
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0030834167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2023
• 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