MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX DUODENAL; STENT,METALLIC,EXPANDABLE,DUODENAL

Model Number	M00565010
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a wallflex duodenal stent was to be implanted in the duodenum to treat an approximate 3cm malignant duodenal stricture during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2024.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent was able to be deployed.However, when the delivery system was attempted to be removed, the stent got caught on the catheter.The stent was then removed together with the delivery system, and another wallflex duodenal stent was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a150207 captures the reportable event of delivery system difficult to remove.

• Brand Name: WALLFLEX DUODENAL
• Common Device Name: STENT,METALLIC,EXPANDABLE,DUODENAL
• 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: 19076046
• Report Number: 3005099803-2024-01510
• Device Sequence Number: 15178496
• Product Code: MUM
• UDI-Device Identifier: 08714729456483
• UDI-Public: 08714729456483
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K062750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/09/2024

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: 06/06/2025
• Device Model Number: M00565010
• Device Catalogue Number: 6501
• Device Lot Number: 0031767434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2023
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 68 KG