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	02/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient was treated for may-thurner syndrome returned with swelling.Vascular access was obtained via popliteal bilateral approach.The target lesion was located in inferior vena cava (ivc).After the two 18x9 stents placed in common iliac vein extended past confluence into ivc, the two 18-4/5.8/75 xxl esophageal balloons were advanced for post dilatation.Both balloons were placed at top of stent, however, during first inflation at 5 atmospheres (atm), the right side balloon ruptured.Another 18x4x75 xxl esophageal balloon was used and both balloons were placed in the middle of stents and inflated simultaneously.However, during first inflation at 5 atm, the right side balloon ruptured again.Both balloons were removed intact, and the procedure was completed with another 18x4x75 xxl esophageal balloon.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: xxl/18-4/5.8/75, batch# 30722108 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 25mm proximal of the distal markerband.The rated burst pressure for this device is 5 atmospheres.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 was treated for may-thurner syndrome returned with swelling.Vascular access was obtained via popliteal bilateral approach.The target lesion was located in inferior vena cava (ivc).After the two 18x9 stents placed in common iliac vein extended past confluence into ivc, the two 18-4/5.8/75 xxl esophageal balloons were advanced for post dilatation.Both balloons were placed at top of stent, however, during first inflation at 5 atmospheres (atm), the right side balloon ruptured.Another 18x4x75 xxl esophageal balloon was used and both balloons were placed in the middle of stents and inflated simultaneously.However, during first inflation at 5 atm, the right side balloon ruptured again.Both balloons were removed intact, and the procedure was completed with another 18x4x75 xxl esophageal balloon.There were no patient complications reported.

• Brand Name: XXL ESOPHAGEAL
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16461998
• Report Number: 2124215-2023-09096
• Device Sequence Number: 2393794
• Product Code: KNQ
• UDI-Device Identifier: 08714729163169
• UDI-Public: 08714729163169
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/21/2023

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: 12/14/2025
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0030722108
• 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: 02/22/2023
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2022
• 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