MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION XXL ESOPHAGEAL; DILATOR, ESOPHAGEAL

Model Number	23375
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture and shaft break occurred requiring additional intervention.The target lesion was located in the non-tortuous and non-calcified vessel.A non-boston scientific stent was placed from a prior procedure and intravascular ultrasound (ivus) was used to determine the distal end of the stent needed to be ballooned.A 16-4/5.8/75 xxl esophageal balloon catheter was advanced for dilation.During first inflation for 1 minute, the balloon ruptured from a stent strut.Resistance was felt when the balloon was being removed.X-ray confirmed that the resistance was coming from the balloon being caught on a stent strut on the proximal end of the stent.A small portion of the stent was fractured and caught in the balloon.The stent strut was attempted to be released from the balloon but were unsuccessful.The sheath advanced to try to free the stent from the balloon, however, part of the balloon detached from the shaft of the balloon catheter and was left in the great saphenous vein (gsv), alongside with the fractured stent.Access into the femoral vein was achieved and a new stent was placed to jailing off the gsv vein to prevent migration of the fractured balloon and stent.The procedure was completed.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: 20547234
• Report Number: 2124215-2024-65620
• Device Sequence Number: 7459987
• Product Code: KNQ
• UDI-Device Identifier: 08714729163060
• UDI-Public: 08714729163060
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2026
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0032331645
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 10/28/2024
• Date Device Manufactured: 08/31/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown