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

Model Number	M00513840
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	10/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022, that an ultraflex esophageal proximal covered stent was used during a stent placement procedure performed on (b)(6) 2022.During the procedure, the patient became uncomfortable, upon checking of the stent, it was noted that a sharp wire protruded from the delivery system.The stent was removed, and another ultraflex esophageal stent was used to complete the procedure.The patient's condition at the conclusion of the procedure was reported to be stable.No further information has been obtained despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation on october 24, 2022 that an ultraflex esophageal proximal covered stent was used during a stent placement procedure performed on (b)(6) 2022.During the procedure, the patient became uncomfortable, upon checking of the stent, it was noted that a sharp wire protruded from the delivery system.The stent was removed and another ultraflex esophageal stent was used to complete the procedure.The patient's condition at the conclusion of the procedure was reported to be stable.Note: no further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of ultraflex esophageal proximal covered stent partially deployed.Block h10: an ultraflex esophageal proximal covered stent and delivery system were received for analysis.The stent was received partially deployed.Visual inspection was performed and no damages or knots were noted to the deployment suture.During functional inspection, the stent was able to be deployed by holding the handle hub in the palm of one hand, grasping and retracting the finger ring with the other hand.No other issues were noted to the stent and delivery system.The reported event of stent partially deployed was confirmed as the stent was received partially deployed.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.It is likely that procedural factors such as lesion characteristics, handling of the device, the technique used by the physician, and normal procedural difficulties encountered during the procedure limited the performance of the device and contributed to the stent being partially deployed.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.

• 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: 15793203
• Report Number: 3005099803-2022-06606
• Device Sequence Number: 11541691
• Product Code: ESW
• UDI-Device Identifier: 08714729716099
• UDI-Public: 08714729716099
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2023

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: 05/06/2023
• Device Model Number: M00513840
• Device Catalogue Number: 1384
• Device Lot Number: 0027261857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2021
• 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 Sex: Unknown