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	12/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the mildly tortuous and severely calcified superficial common iliac vein.A 16-4/5.8/75 xxl balloon dilator was advanced for dilation.However, during the second inflation at 5 atmospheres for 10 seconds, the balloon ruptured.The device was removed and the procedure was completed with another of the same device.No complications were reported, and the patient was in good condition post-procedure.
Additional Manufacturer Narrative
Device was received by manufacturer: the xxl balloon dilator underwent a visual examination.The balloon was identified to have not been folded which indicates that it was subjected to positive pressure.A balloon longitudinal tear was identified.There were no damages or issues noted with the shaft, tip or markerbands noted.The rated burst pressure for this device is 5 atmospheres as per xxl specification.No other issues were identified during analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the mildly tortuous and severely calcified superficial common iliac vein.A 16-4/5.8/75 xxl balloon dilator was advanced for dilation.However, during the second inflation at 5 atmospheres for 10 seconds, the balloon ruptured.The device was removed and the procedure was completed with another of the same device.No complications were reported, and the patient was in good condition post-procedure.

• 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: 18444982
• Report Number: 2124215-2023-75168
• Device Sequence Number: 15420638
• Product Code: KNQ
• UDI-Device Identifier: 08714729163060
• UDI-Public: 08714729163060
• 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): 01/31/2024

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: 03/02/2026
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0031164429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2023
• 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