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	06/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the pulmonary artery.A 18-4/5.8/120 xxl esophageal balloon dilator was advanced for dilatation.The balloon was inflated at which the normal pressure of the device did not reach 5 atmospheres.However, the balloon exploded and no more pressure was applied to the balloon.The procedure was completed with another device.There were no patient complications reported and the patient status was fine.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the pulmonary artery.A 18-4/5.8/120 xxl esophageal balloon dilator was advanced for dilatation.The balloon was inflated at which the normal pressure of the device did not reach 5 atmospheres.However, the balloon exploded and no more pressure was applied to the balloon.The procedure was completed with another device.There were no patient complications reported and the patient status was fine.It was further reported that the target lesion was moderately calcified with mild stenosis.The balloon was inflated two times, however, on the second inflation at 4 atmospheres, the balloon ruptured.The balloon was well removed and no residues left on the patient's body.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the pulmonary artery.A 18-4/5.8/120 xxl esophageal balloon dilator was advanced for dilatation.The balloon was inflated at which the normal pressure of the device did not reach 5 atmospheres.However, the balloon exploded and no more pressure was applied to the balloon.The procedure was completed with another device.There were no patient complications reported and the patient status was fine.It was further reported that the target lesion was moderately calcified with mild stenosis.The balloon was inflated two times, however, on the second inflation at 4 atmospheres, the balloon ruptured.The balloon was well removed and no residues left on the patient's body.
Additional Manufacturer Narrative
Device evaluated by mfr.: xxl/18-4/5.8/120 was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.Blood was identified within the balloon which is evidence of a device leak.A balloon partial circumferential tear was identified located approximately 15mm distal of the proximal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and tactile examination identified no damage or kinks on the shaft of the device.A visual examination of the tip and markerbands identified no damage or any issues that could have contributed to the complaint incident.This concludes the product analysis.

• 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: 14757980
• Report Number: 2134265-2022-07121
• Device Sequence Number: 11086258
• Product Code: KNQ
• UDI-Device Identifier: 08714729163176
• UDI-Public: 08714729163176
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 08/19/2022

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: 11/14/2024
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0028385466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 06/28/2022; 08/18/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 07/06/2022; 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2021
• 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
• Patient Sex: Unknown