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

Model Number	M00513750
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal distal covered stent was used to treat a 9cm malignant stricture in the esophagus during an upper gastrointestinal endoscopy (ugi) with stent placement procedure performed on (b)(6) 2023.The patient's anatomy was very tight and was dilated up to 11mm prior to stent placement.During the procedure, the stent deployment suture became stuck and the stent was unable to deploy.The stent was partially covered by the deployment suture on the delivery system when it was removed from the patient.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
The physician's phone number is (b)(6).Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.
Additional Manufacturer Narrative
Block e1 (initial reporter phone): the physician's phone number is (b)(6).Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Block h10: an ultraflex esophageal distal covered stent and delivery system were received for analysis.The stent was received partially deployed.Visual inspection found the shaft kinked.Functional inspection was performed by pulling the finger ring and the stent was deployed without any problems.No other problems were noted with the stent and delivery system.The reported event of stent partially deployed was confirmed because the stent was received partially deployed.It is most likely that procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied) could have contributed to the observed event of shaft kinked which resulted in the stent being unable to fully deploy during the procedure.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal distal covered stent was used to treat a 9cm malignant stricture in the esophagus during an upper gastrointestinal endoscopy (ugi) with stent placement procedure performed on (b)(6) 2023.The patient's anatomy was very tight and was dilated up to 11mm prior to stent placement.During the procedure, the stent deployment suture became stuck and the stent was unable to deploy.The stent was partially covered by the deployment suture on the delivery system when it was removed from the patient.There were no patient complications reported 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: 17724935
• Report Number: 3005099803-2023-04676
• Device Sequence Number: 7213203
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2024

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: 11/17/2023
• Device Model Number: M00513750
• Device Catalogue Number: 1375
• Device Lot Number: 0028400332
• 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: 08/21/2023
• Supplement Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 52 KG
• Patient Race: Asian