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

Model Number	23375
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that balloon rupture and leak occurred.On (b)(6) 2020, a balloon dilation on the esophagus using an 18-4/5.8/120 xxl balloon dilator was prepared for the procedure.During preparation, a leak test on the catheter noted that the balloon was leaking air.However, a video was provided that showed that a pinhole was found on the balloon, which contributed to the leak where liquid was coming off.The device was removed and replaced for a different model to complete the procedure.There were no patient complications reported.
Event or Problem Description
It was reported that balloon rupture and leak occurred.On (b)(6) 2020, a balloon dilation on the esophagus using an 18-4/5.8/120 xxl balloon dilator was prepared for the procedure.During preparation, a leak test on the catheter noted that the balloon was leaking air.However, a video was provided that showed that a pinhole was found on the balloon, which contributed to the leak where liquid was coming off.The device was removed and replaced for a different model to complete the procedure.There were no patient complications reported.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(4).Device was not returned to the manufacturer; however, medial from the clinical procedure was provided to boston scientific and reviewed by a member of bsc cis.A copy of the media review report was attached to the record.The media review report concluded: a video showed that the balloon was inflated, and a pinhole leak was noted on the balloon material.

• 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: 19007533
• Report Number: 2124215-2024-18374
• Device Sequence Number: 9372205
• Product Code: KNQ
• UDI-Device Identifier: 08714729163176
• UDI-Public: 08714729163176
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2024

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: 04/06/2025
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0029184652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2022
• 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: Male