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

Model Number M00513700

Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

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 that an ultraflex esophageal ng distal released uncovered stent was to be implanted in the esophagus during an esophageal stent implantation procedure performed on (b)(6) 2022.During the procedure, the black deployment suture of the ultraflex esophageal stent was found to be entangled and the ultraflex esophageal stent was unable to be deployed, the ultraflex esophageal stent was removed from the patient and the procedure was completed with another ultraflex esophageal stent.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.Note: this complaint has been deemed an mdr reportable event based on the product investigation which revealed that the stent was partially deployed.Please see block h10 for full investigation detail.

Manufacturer Narrative

(b)(4).The ultraflex esophageal ng distal release uncovered stent and delivery system were received for analysis.Visual examination of the returned device found the stent was partially deployed.Microscopic inspection revealed no damage or knots in the black stent deployment suture.Functional inspection was performed, and the stent was released gradually from the delivery system by holding the handle hub in the palm of one hand, grasping and retracting the finger ring with the other hand no other issues were noted to the stent and delivery system.The reported event of stent deployment suture knotted and stent failure to deploy were not confirmed.No issues were noted to the stent deployment suture.Although the reported event of stent failure to deploy has been verified as per visual inspection as the stent was returned partially deployed; functional evaluation was performed and revealed the stent was released from the delivery system without any resistance.The investigation concluded that the observed problem was most likely due to procedural factors encountered during the procedure.It may be that lesion characteristics, handling and manipulation of the device, the techniques used by the user, and/or normal procedural difficulties encountered during the procedure, limited the performance of the device and contributed to partial stent deployment.Therefore, review and analysis of all available information indicated the most probable cause adverse event related to procedure.A product labeling review identified that the device was used per the directions for use (dfu)/product label.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• 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: 16281012
• MDR Text Key: 308617888
• Report Number: 3005099803-2023-00376
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729716129
• UDI-Public: 08714729716129
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K091816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: M00513700
• Device Catalogue Number: 1370
• Device Lot Number: 0028775444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2022
• 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
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 58 KG