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

Model Number M00513730

Device Problems Activation, Positioning or Separation Problem (2906); Difficult to Advance (2920); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientifc corporation on october 23, 2020 that an ultraflex esophageal ng distal release covered stent was to be implanted in the middle of the esophagus to treat an advanced esophageal cancer during a stent placement procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the stent was advanced through the guidewire and noticed that the tip of the delivery system was partially deployed and it was difficult to pass through the pharynx.The stent was removed from the patient partially covered by the stent deployment suture and the procedure was not completed due to device availability.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: medical device problem code a27 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: an ultraflex esophageal ng distal release covered stent and delivery system were received for analysis.The stent was received partially deployed.Visual inspection was performed and it was noted that the shaft was kinked.No other issues were noted to the stent and delivery system.The reported event of stent partially deployed was confirmed; however, the reported event of delivery system difficult to advance could not be confirmed as this failure occurred during the procedure and is not possible to replicate in the laboratory of analysis.The investigation concluded that the reported events and the observed failure were likely due to factors encountered during the procedure.It is possible that the technique used by the user during the deployment of the stent caused the kink in the shaft.Furthermore, the kink in the shaft could have caused the difficulty to advance the delivery system in the pharynx which resulted in the removal of a partially deployed stent.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to the procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation on october 23, 2020 that an ultraflex esophageal ng distal release covered stent was to be implanted in the middle of the esophagus to treat an advanced esophageal cancer during a stent placement procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the stent was advanced through the guidewire and noticed that the tip of the delivery system was partially deployed and it was difficult to pass through the pharynx.The stent was removed from the patient partially covered by the stent deployment suture and the procedure was not completed due to device availability.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10842689
• MDR Text Key: 226077760
• Report Number: 3005099803-2020-05331
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729716150
• UDI-Public: 08714729716150
• Combination Product (y/n): N
• PMA/PMN Number: K091816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/04/2021

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 Expiration Date: 09/03/2021
• Device Model Number: M00513730
• Device Catalogue Number: 1373
• Device Lot Number: 0024371560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 07/13/2021
• Supplement Dates FDA Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 70