MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX ESOPHAGEAL; PROSTHESIS, ESOPHAGEAL

Model Number M00516900

Device Problems Positioning Failure (1158); Detachment of Device or Device Component (2907)

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

Event Date 03/20/2024

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a wallflex esophageal partially covered stent was to be implanted in the esophagus to treat an esophageal cancer during a stent placement procedure performed on (b)(6) 2024.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent was not able to be deployed, and it was noted that the white distal tip was inside the patient's esophagus under pediatric gastroscope.The guidewire was then removed, and the white distal tip came out with the wire.A different device was used to complete the procedure.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a0501 captures the reportable event of tip detachment of device or device component.

• Brand Name: WALLFLEX ESOPHAGEAL
• Type of Device: PROSTHESIS, 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19118250
• MDR Text Key: 340970171
• Report Number: 3005099803-2024-01583
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729765240
• UDI-Public: 08714729765240
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K073266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2024

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
• Device Operator: Health Professional
• Device Model Number: M00516900
• Device Catalogue Number: 56453
• Device Lot Number: 0032915745
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2023
• 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