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

Model Number	23375
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon shaft perforation occurred.The patient presented with iliac vein stenosis and underwent stenting.A 18-6/5.8/75 xxl esophageal balloon catheter was advanced for post-dilatation.However, during inflation, blood leakage was found inside the balloon and was noted to be perforated.The device was removed and the procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon shaft perforation occurred.The patient presented with iliac vein stenosis and underwent stenting.A 18-6/5.8/75 xxl esophageal balloon catheter was advanced for post-dilatation.However, during inflation, blood leakage was found inside the balloon and was noted to be perforated.The device was removed and the procedure was completed with another of same device.No patient complications were reported.It was further reported that the balloon material ruptured during the procedure and was not shaft perforation as what was previously reported.The target lesion was more than 50% critical stenosed, severely tortuous and non-calcified.The patient was in good condition post-procedure.

• 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: 16229964
• Report Number: 2124215-2023-02161
• Device Sequence Number: 5272866
• Product Code: KNQ
• UDI-Device Identifier: 08714729163190
• UDI-Public: 08714729163190
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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
• Report Date (Section B): 02/19/2023

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: 01/29/2024
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0026717496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2021
• 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 Age: 75 YR
• Patient Sex: Male
• Patient Weight: 110 KG