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

Model Number	23375
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 18-6/5.8/75 xxl esophageal balloon catheter was advanced for dilatation.However, during inflation at 5 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.
Event or Problem Description
It was reported that balloon rupture occurred.A 18-6/5.8/75 xxl esophageal balloon catheter was advanced for dilatation.However, during inflation at 5 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.It was further reported that the balloon ruptured on the first inflation for 5 few seconds.The device was simply pulled out after it ruptured.
Additional Manufacturer Narrative
Device evaluated by mfr: an xxl device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured 12mm in length and extended from a position 1mm proximal of the distal markerband to 13mm proximal of the distal markerband.An examination of the balloon material and the tip region identified no issues which could potentially have contributed to this complaint.A visual and tactile examination identified multiple shaft kinks.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 balloon rupture occurred.A 18-6/5.8/75 xxl esophageal balloon catheter was advanced for dilatation.However, during inflation at 5 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.It was further reported that the balloon ruptured on the first inflation for 5 few seconds.The device was simply pulled out after it ruptured.

• 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: 14031136
• Report Number: 2134265-2022-04086
• Device Sequence Number: 6300484
• Product Code: KNQ
• UDI-Device Identifier: 08714729163190
• UDI-Public: 08714729163190
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2022

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: 04/07/2022
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0023611459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 04/06/2022; 07/18/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 04/19/2022; 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2019
• 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
• Patient Sex: Unknown