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

Model Number M00516910

Device Problem Unsealed Device Packaging (1444)

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

Event Date 11/29/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation on (b)(6) 2022 that a wallflex esophageal stent was to be implanted in the esophagus to treat a 6cm malignant stricture due to esophageal cancer during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2022.The patient anatomy was not dilated prior to stent placement.During the procedure, the ro band marker was observed to be incorrectly positioned and the wallfex esophageal stent (the subject of mfr.Report# 3005099803-2022-07566) was deployed proximal to the stricture.The wallflex esophageal stent was removed from the patient with rat-tooth combo forceps.A second wallflex esophageal stent (the subject of this report) was opened, and the inner sterile pouch was found broken.The procedure was completed with a 3rd wallfex esophageal stent.There were no patient complications reported as a result of this event.

Manufacturer Narrative

(b)(4).

• 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: 15999185
• MDR Text Key: 308026789
• Report Number: 3005099803-2022-07565
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729765257
• UDI-Public: 08714729765257
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2022
• Device Model Number: M00516910
• Device Catalogue Number: 1691
• Device Lot Number: 0026540335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2020
• 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