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)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	06/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture, difficulty removal, and a balloon break occurred requiring surgical intervention.The 70% stenosed target lesion was located in right common iliac vein.A 18-6/5.8/75 xxl esophageal balloon catheter was advanced for post dilatation.However, during fourth inflation at 2 atmospheres for 3 minutes, the balloon ruptured.During removal of the balloon over a 0.035 guidewire, the distal half of the balloon broke and was stuck inside the lesion.The remaining portion of the balloon was successfully removed.A snare was used to remove the rest of the balloon from the patient, but was unsuccessful.The patient was stable and sent to the hospital to surgically remove the rest of the balloon.
Additional Manufacturer Narrative
H6: patient codes: insufficient information was omitted and added foreign body in patient h6: impact codes: additional device required and serious injury/illness/impairment were omitted.
Event or Problem Description
It was reported that balloon rupture, difficulty removal, and a balloon break occurred requiring surgical intervention.The 70% stenosed target lesion was located in right common iliac vein.A 18-6/5.8/75 xxl esophageal balloon catheter was advanced for post dilatation.However, during fourth inflation at 2 atmospheres for 3 minutes, the balloon ruptured.During removal of the balloon over a 0.035 guidewire, the distal half of the balloon broke and was stuck inside the lesion.The remaining portion of the balloon was successfully removed.A snare was used to remove the rest of the balloon from the patient, but was unsuccessful.The patient was stable and sent to the hospital to surgically remove the rest of the 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15085115
• Report Number: 2124215-2022-24825
• Device Sequence Number: 4034681
• Product Code: KNQ
• UDI-Device Identifier: 08714729163190
• UDI-Public: 08714729163190
• 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): 08/19/2022

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: 12/02/2024
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0028492070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Race: White