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

Model Number	M001145320
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with left iliac vein compression and underwent stenting.After flushing, pre-dilatation was performed using a 10x12 mustang balloon catheter followed by a 14-6/5.8/75 xxl vascular balloon catheter.During inflation of the xxl balloon at 5 atmospheres, it was noted that the liquid in the pressure pump changed from transparent to red, the pressure would not rise, and the liquid in the pressure pump decreased.After removal, a hole was noted on the balloon.The procedure was completed with another of different device.No patient complications were reported, and the patient status was stable.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital device evaluated by mfr: the complaint device was received for product analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A balloon pinhole was identified located approximately 22mm proximal of the distal markerband.The rated burst pressure for this device is 8 atmospheres as per specification.A visual and tactile examination identified no kinks or damage to the shaft of the device.This concludes the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with left iliac vein compression and underwent stenting.After flushing, pre-dilatation was performed using a 10x12 mustang balloon catheter followed by a 14-6/5.8/75 xxl vascular balloon catheter.During inflation of the xxl balloon at 5 atmospheres, it was noted that the liquid in the pressure pump changed from transparent to red, the pressure would not rise, and the liquid in the pressure pump decreased.After removal, a hole was noted on the balloon.The procedure was completed with another of different device.No patient complications were reported, and the patient status was stable.

• 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: 20904185
• Report Number: 2124215-2024-78330
• Device Sequence Number: 4070671
• Product Code: LIT
• UDI-Device Identifier: 08714729190486
• UDI-Public: 08714729190486
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025

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: 02/27/2026
• Device Model Number: M001145320
• Device Catalogue Number: M001145320
• Device Lot Number: 0031135891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2023
• 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 Age: 79 YR
• Patient Sex: Male
• Patient Weight: 77 KG