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	10/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with may thurner syndrome and was to undergo venogram.The 80% stenosed target lesion was located in the mildly tortuous and severely calcified common iliac vein.After an 18x90 wallstent was placed, the two 18-4/5.8/75 xxl esophageal balloons were advanced and inflated at 5 atmospheres (atm) at 5mm below the proximal end of the stent.The balloons were deflated and moved down for second inflations.However, during the second inflation at 5 atm for few seconds, one 18-4/5.8/75 xxl esophageal balloon failed to hold pressure and was ruptured.When the balloon was deflated, blood was noticed in indeflator.The balloon was removed intact, and the procedure was completed with another 18x4 xxl balloon catheter.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: xxl/18-4/5.8/75 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 observed inside the balloon is indicative of a device leak.The balloon was attached to an encore inflation device, subjected to positive pressure and liquid was observed to be leaking from a balloon pinhole located approximately 4mm proximal of the tip bond.The rated burst pressure for this device is 5 atmospheres as per xxl 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 presented with may thurner syndrome and was to undergo venogram.The 80% stenosed target lesion was located in the mildly tortuous and severely calcified common iliac vein.After an 18x90 wallstent was placed, the two 18-4/5.8/75 xxl esophageal balloons were advanced and inflated at 5 atmospheres (atm) at 5mm below the proximal end of the stent.The balloons were deflated and moved down for second inflations.However, during the second inflation at 5 atm for few seconds, one 18-4/5.8/75 xxl esophageal balloon failed to hold pressure and was ruptured.When the balloon was deflated, blood was noticed in indeflator.The balloon was removed intact, and the procedure was completed with another 18x4 xxl balloon catheter.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: 17995051
• Report Number: 2124215-2023-58530
• Device Sequence Number: 17831247
• 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): 11/02/2023

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: 03/12/2026
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0031218151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2023
• 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