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

Model Number M00513730

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

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

Event Date 05/19/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an ultraflex esophageal ng distal release covered stent was to be implanted in the esophagus during an esophageal stent placement procedure performed on (b)(6) 2023.During the procedure, the stent could not be deployed.Another esophageal stent was used to complete the procedure.There were no reported patient complications as a result of this event.The patient's condition following the procedure was reported to be stable.No further information has been obtained despite good faith efforts.Note: this event has been deemed an mdr reportable event based on the investigation finding of stent partially deployed.Please see block h10 for the full investigation details.

Manufacturer Narrative

Block h6: imdrf device code a15 captures the reportable investigation finding of stent partially deployed.Block h10: the ultraflex esophageal ng distal release covered stent and delivery system were received for analysis.A visual inspection was performed and revealed the stent was partially deployed on the delivery system and that the shaft was bent.The deployment suture was inspected, and no damages or knots were noted.Functional examination was performed, and the stent was released gradually from the delivery system by holding the handle hub in the palm of one hand and grasping and retracting the finger ring with the other hand.No other damages were noted with the stent or delivery system.Although the stent was returned partially deployed on the delivery system; product analysis could not confirm the reported event of stent unable to deploy as the stent was released from the delivery system without resistance during device analysis.The investigation concluded that the damages observed were most likely due to procedural factors such as characteristics of the lesion, handling of the device, and the technique, limited the performance of the device and contributed to stent being unable to deploy.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: 17399178
• MDR Text Key: 320217639
• Report Number: 3005099803-2023-04038
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729716150
• UDI-Public: 08714729716150
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00513730
• Device Catalogue Number: 1373
• Device Lot Number: 0030562699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2022
• 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