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

Model Number 23375

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2020

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The 89% stenosed target lesion was located in the non-calcified left common iliac vein.After a 0.035 non-bsc guidewire was passed, a 18-6/5.8/75 xxl esophageal balloon catheter was advanced for dilation.However, during first inflation at 3 atmospheres for 3 minutes, the balloon ruptured.The device was removed and replaced with second xxl balloon of the same size.But, during first inflation at 3 atmospheres for 2 minutes, the balloon ruptured as well.After removing the device, the procedure was completed with another balloon of the same size.There were no patient complications reported and the patient is doing well.

• Brand Name: XXL ESOPHAGEAL
• Type of Device: 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: 10473460
• MDR Text Key: 205014489
• Report Number: 2134265-2020-11092
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 08714729163190
• UDI-Public: 08714729163190
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2023
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0024990261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE: 0.035 GLIDE WIRE
• Patient Age: 70 YR