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

Model Number	23375
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The >50% stenosed target lesion was located in the moderately tortuous and non-calcified iliac artery.A 16-4/5.8/75 xxl balloon catheter was advanced for dilation.However, it was noted that the balloon broke while inflating inside a wallstent.The balloon was pulled out through the sheath and the procedure was completed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: xxl/16-4/5.8/75 was returned for analysis.A visual examination identified a complete circumferential tear of the balloon material located approximately 50mm distal of the proximal sleeve of the balloon.The proximal section of balloon material was also torn longitudinally beginning at the circumferential tear and extending approximately 25mm proximally.The distal section of the device including a section of balloon material, a section of shaft, both markerbands and the tip were not returned for analysis.This type of damage is consistent with excessive tensile force being applied to the device.The rate of burst pressure of this device is 5atm (atmospheres).A visual and tactile examination found the shaft to have been detached and severely stretched/damaged at approximately 45mm distal of the proximal balloon sleeve.The distal section of the device including a section of balloon material, a section of shaft, both markerbands and the tip were not returned for analysis.This type of damage is consistent with excessive tensile force being applied to the device.The shaft of the proximal section of the device was also kinked at more than one location.A visual examination identified a section of balloon material, a section of shaft, both markerbands and the tip were not returned for analysis.A visual examination of the device identified that a section of balloon material, a section of shaft, both markerbands and the tip were not returned for analysis.
Event or Problem Description
It was reported that shaft break occurred.The >50% stenosed target lesion was located in the moderately tortuous and non-calcified iliac artery.A 16-4/5.8/75 xxl balloon catheter was advanced for dilation.However, it was noted that the balloon broke while inflating inside a wallstent.The balloon was pulled out through the sheath and the procedure was completed with a different device.There were no patient complications reported.It was further reported that the balloon ruptured while inflating, and the shaft did not break as previously reported.
Event or Problem Description
It was reported that shaft break occurred.The >50% stenosed target lesion was located in the moderately tortuous and non-calcified iliac artery.A 16-4/5.8/75 xxl balloon catheter was advanced for dilation.However, it was noted that the balloon broke while inflating inside a wallstent.The balloon was pulled out through the sheath and the procedure was completed with a different device.There were no patient complications reported.It was further reported that the balloon ruptured while inflating, and the shaft did not break as previously 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16942920
• Report Number: 2124215-2023-24368
• Device Sequence Number: 19667984
• Product Code: KNQ
• UDI-Device Identifier: 08714729163060
• UDI-Public: 08714729163060
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 06/15/2023

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: 12/18/2025
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0030739262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 05/17/2023; 05/31/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 05/23/2023; 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2022
• 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