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

Model Number	M00513710
Medical Device Problem Codes	Break (1069); Unraveled Material (1664); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).An ultraflex esophageal ng distal release uncovered stent and delivery system were received for analysis.The stent was returned fully deployed and the position of the stent was at the proximal section of the delivery handle.Visual examination of the returned device found the deployment suture was inside the stent.The stent was partially unraveled, some stent wires were broken, and the shaft was crossing the stent.A destructive inspection was performed and the finger ring of the deployment suture was cut in order to remove the cord from the stent.The stent deployment suture was found in good condition.No other issues were noted to the stent and delivery system.The reported event of stent deployment suture knotted and stent partially deployed were not confirmed.The stent was received fully deployed and the stent deployment suture was not knotted.The damages noted to the returned stent were most likely due to procedural factors encountered during the procedure.Handling and manipulation of the device could lead to the shaft crossing the stent and difficulty positioning the stent resulting in broken stent wires and stent unraveled.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal ng distal release uncovered stent was to be implanted to treat a 6-7 cm malignant esophageal stricture during a procedure performed on (b)(6) 2021.During the procedure, the stent was attempted to be deployed but the black deployment suture got knotted.The stent was partially deployed on the delivery system when it was removed from the patient.Another ultraflex esophageal stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition at the end of the procedure was reported to be stable.Note: this complaint has been deemed mdr reportable based on the investigation result of stent detached and stent unraveled.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• Common Device Name: 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: 13236191
• Report Number: 3005099803-2021-08225
• Device Sequence Number: 4243837
• Product Code: ESW
• UDI-Device Identifier: 08714729716136
• UDI-Public: 08714729716136
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K091816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/12/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: M00513710
• Device Catalogue Number: 1371
• Device Lot Number: 0027065481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 49 KG