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

Model Number 23375

Device Problems Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2024

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: the 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.Blood observed inside the balloon is indicative of a device leak.The balloon was attached to an encore inflation device, subjected to positive pressure and liquid was observed to be leaking from a balloon pinhole located approximately 10mm proximal of the distal markerband.The rated burst pressure for this device is 5 atmospheres.A visual and tactile examination identified a kink to the shaft of the device located approximately 390mm distal of the manifold of the device.This type of damage is consistent with excessive force being applied to the device.A visual examination identified no issues with the tip of the device.

Event Description

Reportable based on device analysis completed on 29-feb-2024.It was reported that balloon leak occurred.The 70% stenosed target lesion was located in the mild tortuous and severely calcified vessel.During the procedure, after 8x90 venous wallstents were placed, a 18-6/5.8/75 xxl esophageal balloon catheter was advanced into bilateral bifurcation compression and another 18-6/5.8/75 xxl esophageal balloon advanced into the bilateral common iliac vein (civ) compression.Both balloons were placed just below the proximal part of the stents and the physician started the kissing balloon technique, but neither balloons would reach 5 atmospheres.A balloon leak was noted.The balloons were replaced, and the case was finished successfully.No complications were reported.However, returned device analysis revealed a balloon pinhole.

• Brand Name: XXL ESOPHAGEAL
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18946589
• MDR Text Key: 338374044
• Report Number: 2124215-2024-17094
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0032767540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2023
• 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