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

Model Number	23375
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon burst occurred.The >50% stenosed target lesion was located in the mildly tortuous and moderately calcified vessel.During the procedure, an 18x90 wallstent was placed bilaterally on the inferior vena cava (ivc) through the common iliac vein (civ).Then, two 18-4/5.8/75 xxl esophageal balloon catheters were placed at the proximal of the stent for post-dilation.However, when the balloon catheters were inflated at 5 atmospheres for a few seconds, this balloon would not hold pressure, and when negative pressure was applied, there was blood returning to the indeflator.Consequently, the balloon burst.The balloon was removed fully intact, and the procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that a balloon burst occurred.The >50% stenosed target lesion was located in the mildly tortuous and moderately calcified vessel.During the procedure, an 18x90 wallstent was placed bilaterally on the inferior vena cava (ivc) through the common iliac vein (civ).Then, two 18-4/5.8/75 xxl esophageal balloon catheters were placed at the proximal of the stent for post-dilation.However, when the balloon catheters were inflated at 5 atmospheres for a few seconds, this balloon would not hold pressure, and when negative pressure was applied, there was blood returning to the indeflator.Consequently, the balloon burst.The balloon was removed fully intact, and the procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
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 longitudinal tear was identified in the balloon material.The tear measured 5mm in length and extended from a position 6mm proximal of the proximal markerband to 1mm proximal of the proximal markerband.The rated burst pressure for this device is 8 atmospheres as per specification.A visual and tactile examination identified no issues with the shaft.A visual examination identified no issues with the tip of the device.This concludes the product analysis.

• Brand Name: XXL ESOPHAGEAL
• 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: 18512765
• Report Number: 2124215-2024-01668
• Device Sequence Number: 15250929
• Product Code: KNQ
• UDI-Device Identifier: 08714729163169
• UDI-Public: 08714729163169
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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): 02/08/2024

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: 02/07/2026
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0031014218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/05/2024
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 01/15/2024
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STENT - 18X90 WALLSTENT; STENT - 18X90 WALLSTENT
• Patient Sex: Unknown