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	01/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: a xxl device 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 present in balloon which is indicative of a leak.The balloon was attached to an encore inflation device, subjected to positive pressure and di water was observed to be leaking from a balloon pinhole located approximately 20mm distal from the distal markerband.An examination of the balloon material and the tip region identified no issues which could potentially have contributed to this complaint.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.A visual examination identified no issues with the tip of the device.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosis was more than 80% located in the mildly tortuous and severely calcified common iliac vein.During the procedure, a 18x90 wallstent self-expanding stent was placed and was post-dilated.A /18-4/5.8/75, xxl esophageal balloon catheter was advanced for dilation just below the proximal end of the stent.A kissing technique was performed bilaterally.However, during first inflation, the balloon would not hold pressure and at 5 atmospheres for a few seconds, the balloon ruptured.When negative pressure was applied, there was blood returned in the indeflator.The device was fully intact upon removal, and no fragments left inside the patient.The procedure was completed with another xxl balloon catheter.No 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: 18592243
• Report Number: 2124215-2024-04359
• Device Sequence Number: 20862234
• 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
• Report Date (Section B): 01/26/2024

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: 04/16/2026
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0031439464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2023
• 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