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	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent a venous stenting.The 60-70% stenosed target lesion was located in the non-tortuous and mildly calcified bilateral common iliac vein/confluence.An 8-6/5.8/75 xxl balloon dilator was advanced; however, during the first inflation at 5 atmospheres just to get wall apposition, the mid balloon burst.Another of the same model was used, but it had also burst the exact same was which was on the first inflation, 5 atmospheres, towards the wall apposition, mid balloon.Both devices were removed intact over the wire without separating the balloons, and the procedure was completed using a different device.No complications were reported, and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A balloon longitudinal teat was noted beginning approximately 3mm distal of the distal markerband and extending approximately 3mm distally.The rated burst pressure for this device is 5 atmospheres as per 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.
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent a venous stenting.The 60-70% stenosed target lesion was located in the non-tortuous and mildly calcified bilateral common iliac vein/confluence.An 8-6/5.8/75 xxl balloon dilator was advanced; however, during the first inflation at 5 atmospheres just to get wall apposition, the mid balloon burst.Another of the same model was used, but it had also burst the exact same was which was on the first inflation, 5 atmospheres, towards the wall apposition, mid balloon.Both devices were removed intact over the wire without separating the balloons, and the procedure was completed using a different device.No complications were reported, and the patient status was stable.

• 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: 18743939
• Report Number: 2124215-2024-10150
• Device Sequence Number: 6380804
• Product Code: KNQ
• UDI-Device Identifier: 08714729163190
• UDI-Public: 08714729163190
• 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): 03/07/2024

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 Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0032699433
• 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: 02/01/2024
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2023
• 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