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	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 16-6/5.8/75 xxl esophageal balloon was advanced for dilatation.However, during the procedure, the balloon burst.The device was removed and replaced.The procedure was completed.There were no patient complications reported.
Event or Problem Description
It was reported that balloon rupture occurred.A 16-6/5.8/75 xxl esophageal balloon was advanced for dilatation.However, during the procedure, the balloon burst.The device was removed and replaced.The procedure was completed.There were no patient complications reported.
Additional Manufacturer Narrative
Updated fields: e1.Initial reporter title-from no information to dr.E1.Initial reporter first name-from no information to (b)(6).E1.Initial reporter first name-from no information to (b)(6).E1.Initial reporter facility name-from boston scientific corporation to (b)(6).E1.Initial reporter address 1-(b)(6).E1.Initial reporter city-from (b)(6).E1.Initial reporter state-from (b)(6).E1.Initial reporter zip/post code-from (b)(6).E1.Initial reporter phone-from (b)(6).E3.Occupation-from other health care professional to physician.

• 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: 18102813
• Report Number: 2124215-2023-62971
• Device Sequence Number: 7863103
• Product Code: KNQ
• UDI-Device Identifier: 08714729163114
• UDI-Public: 08714729163114
• 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,Followup
• Report Date (Section B): 11/14/2023

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: 10/24/2025
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0030417006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2022
• 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