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

Model Number	23375
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Event date was not reported and was approximated to (b)(6) 2021.
Event or Problem Description
It was reported that the balloon broke off inside the patient, and the patient is now deceased.A 16mm x 4cm x 120cm xxl esophageal balloon dilatation catheter was selected for use in a procedure.The balloon broke off in the patient.The balloon became stuck in the sheath and was able to be pulled out of the patient.It was reported the patient is now deceased, but reported to not be related to the broken xxl balloon.
Additional Manufacturer Narrative
B3.Date of event: event date was not reported and was approximated to (b)(6) 2021.Device evaluated by manufacturer: received xxl device for analysis.Part of the device was received detached and was inserted in the customers introducer sheath.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The balloon was attached to a part of the shaft that was detached from the device.A visual and tactile examination identified a shaft break 3mm from the proximal balloon bond.A visual examination identified no issues with the tip of the device that could have contributed to the complaint incident.
Event or Problem Description
It was reported that the balloon broke off inside the patient, and the patient is now deceased.A 16mm x 4cm x 120cm xxl esophageal balloon dilatation catheter was selected for use in a procedure.The balloon broke off in the patient.The balloon became stuck in the sheath and was able to be pulled out of the patient.It was reported the patient is now deceased, but reported to not be related to the broken xxl balloon.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13065001
• Report Number: 2134265-2021-16066
• Device Sequence Number: 17598232
• Product Code: KNQ
• UDI-Device Identifier: 08714729163084
• UDI-Public: 08714729163084
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2022

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: 06/25/2022
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0024014199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/06/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2019
• 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: Death
• Patient Sex: Unknown