MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION XXL ESOPHAGEAL; 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	03/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon burst occurred.The 80% stenosed target lesion was located in the mildly tortuous and severely calcified common iliac vein.A 16-6/5.8/75 xxl esophageal was selected for use.During the procedure, the balloon burst upon first inflation at 5 atmospheres for a few seconds.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an xxl balloon catheter.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 and was located in the mid region of the balloon.The rated burst pressure for this device is 8 atmospheres as per xxl specification.A visual and tactile examination identified no issues with the shaft of the device.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 a balloon burst occurred.The 80% stenosed target lesion was located in the mildly tortuous and severely calcified common iliac vein.A 16-6/5.8/75 xxl esophageal was selected for use.During the procedure, the balloon burst upon first inflation at 5 atmospheres for a few seconds.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications were reported.

• 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: 19047214
• Report Number: 2124215-2024-20098
• Device Sequence Number: 18263438
• Product Code: KNQ
• UDI-Device Identifier: 08714729163114
• UDI-Public: 08714729163114
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2024

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: 05/11/2026
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0031605130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2023
• 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