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	01/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion with a significant bend of <45 degrees was located in the non-tortuous and moderately calcified iliac vein.A 14-6/5.8/75 xxl vascular balloon catheter was advanced for dilation.However, during initial inflation, when reached the standard atmospheric pressure, the contrast agent spilled, and the balloon was ruptured.The device was removed directly, and the procedure was completed with a different device.There were no patient complications reported, and the patient was in stable condition.
Additional Manufacturer Narrative
Xxl/14-6/5.8/75 was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood observed inside the balloon is indicative of a device leak.The balloon was attached to an encore inflation device, subjected to positive pressure and liquid was observed to be leaking from a balloon pinhole located approximately at the center of the balloon.The rated burst pressure for this device is 8 atmospheres as per xxl specification.A visual and tactile examination identified no kinks or damage to the shaft of the device.A visual examination identified no issues with the tip of the device.This concludes the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion with a significant bend of <45 degrees was located in the non-tortuous and moderately calcified iliac vein.A 14-6/5.8/75 xxl vascular balloon catheter was advanced for dilation.However, during initial inflation, when reached the standard atmospheric pressure, the contrast agent spilled, and the balloon was ruptured.The device was removed directly, and the procedure was completed with a different device.There were no patient complications reported, and the patient was in stable condition.It was further reported that the balloon was ruptured at 5 atmospheres for 10 seconds.In addition, the device was removed completely from the body through a long sheath.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion with a significant bend of <45 degrees was located in the non-tortuous and moderately calcified iliac vein.A 14-6/5.8/75 xxl vascular balloon catheter was advanced for dilation.However, during initial inflation, when reached the standard atmospheric pressure, the contrast agent spilled, and the balloon was ruptured.The device was removed directly, and the procedure was completed with a different device.There were no patient complications reported, and the patient was in stable condition.It was further reported that the balloon was ruptured at 5 atmospheres for 10 seconds.In addition, the device was removed completely from the body through a long sheath.

• 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: 16196181
• Report Number: 2124215-2023-01537
• Device Sequence Number: 6066792
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2023

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: 04/07/2025
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0029192334
• 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: 01/10/2023
• Supplement Date Received by Manufacturer: 02/02/2023; 03/10/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 02/06/2023; 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2022
• 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
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 65 KG