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	03/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The non-stenosed target lesion was located in the mildly tortuous and mildly calcified common iliac vein.A 14-6/5.8/75 xxl vascular balloon dilator was advanced for post-dilatation.However, during the second inflation at approximately 6 atmospheres, the balloon ruptured.The device was removed, and the procedure was completed.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: an xxl device was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured 12mm in length and was located on the distal region of the balloon.An examination of the balloon material and the tip region identified no issues.The rated burst pressure for this device is 8 atmospheres as per xxl specification.A visual and tactile examination of the shaft identified no issues.A visual examination identified no issues with the tip of the device that could have contributed to the complaint incident.
Event or Problem Description
It was reported that balloon rupture occurred.The non-stenosed target lesion was located in the mildly tortuous and mildly calcified common iliac vein.A 14-6/5.8/75 xxl vascular balloon dilator was advanced for post-dilatation.However, during the second inflation at approximately 6 atmospheres, the balloon ruptured.The device was removed, and the procedure was completed.There were no patient complications nor injuries 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16580131
• Report Number: 2124215-2023-12558
• Device Sequence Number: 19254512
• Product Code: LIT
• UDI-Device Identifier: 08714729190486
• UDI-Public: 08714729190486
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2023

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: 10/19/2025
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0030388574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2022
• 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
• Patient Sex: Male