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

Model Number	M00513750
Medical Device Problem Codes	Difficult to Remove (1528); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.Imdrf device code a150207 captures the reportable event of delivery system difficult to remove.
Event or Problem Description
It was reported to boston scientific corporation on june 23, 2023, that an ultraflex esophageal distal release covered stent was to be implanted in the mid esophagus to treat a 11cm malignant lesion due to esophageal cancer during an esophageal stenting procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent was unable to fully expand and got caught on the delivery system during removal.The stent was removed together with the delivery system and another ultraflex esophageal stent was used to complete the procedure.There were no patient complications as a result of this event.

• 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: 17294787
• Report Number: 3005099803-2023-03726
• Device Sequence Number: 19761838
• Product Code: ESW
• UDI-Device Identifier: 08714729649113
• UDI-Public: 08714729649113
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/10/2023

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: 07/12/2024
• Device Model Number: M00513750
• Device Catalogue Number: 1375
• Device Lot Number: 0029753068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2022
• 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 Sex: Unknown
• Patient Race: Asian