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

Model Number 23375

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 12/01/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event was estimated as (b)(6) 2019 based on the initial event aware date of (b)(6)2019.An xxl /14-6/5.8/75 was returned for analysis.A visual examination identified that the balloon wings were in a relaxed state and had been subjected to positive pressure.A visual and microscopic examination found the balloon material to have 2 small longitudinal tears at the location of the distal marker band.The first, measuring approximately 10mm and the second measuring 5 mm.An examination of the balloon material and the distal markerband identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination of the marker bands identified no issues which may potentially have contributed to the complaint incident.The marker bands were not found to be raised, cracked or damaged in any way.A visual and tactile examination found no issues with the shaft of the device.A visual and tactile examination identified no damage to the tip which may have potentially contributed to the complaint incident.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 7 oct 2020.It was reported that a balloon leak occurred.The patient presented for left iliac venous trunk angioplasty due to post-thrombotic syndrome.When an xxl/14-6/5.8/75 vascular balloon was removed from the package and tested, a leak was noted.The device could not be used and the procedure was completed with another.However, device analysis revealed two small longitudinal tears in the balloon material.

• Brand Name: XXL VASCULAR
• 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: 10744681
• MDR Text Key: 213420417
• Report Number: 2134265-2020-14904
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729190486
• UDI-Public: 08714729190486
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K150303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2021
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0022535812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2018
• 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