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

Model Number	M00514200
Medical Device Problem Codes	Failure to Advance (2524); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: the initial reporter's phone number is (b)(6).Block h6: imdrf device code a15 captures the reportable event of ultraflex esophageal stent partially deployed.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal covered distal stent was used to treat a 3cm malignant esophageal stenosis during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the device was unable to cross the lesion due to severe stenosis and the stent could not be released when deployment was attempted.The procedure was completed with a different device.There were no patient complications 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
• 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: 18173089
• Report Number: 3005099803-2023-06301
• Device Sequence Number: 7687632
• Product Code: ESW
• UDI-Device Identifier: 08714729121190
• UDI-Public: 08714729121190
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/20/2023

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: 06/04/2023
• Device Model Number: M00514200
• Device Catalogue Number: 1420
• Device Lot Number: 0027435215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2021
• 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: 54 YR
• Patient Sex: Male
• Patient Weight: 65 KG