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

Model Number	M00565020
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable event of procedure cancelled post-sedation.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral duodenal stent was to be implanted in the duodenum to treat stomach cancer during a procedure performed on (b)(6) 2024.During the procedure, the stent was unable to be deployed.Due to physician discretion, it was decided to terminate the procedure without placing any implant or device.Reportedly, the patient was under palliative management and passed away later on an unknown date due to reasons not related to the reported procedure.
Additional Manufacturer Narrative
Blocks b5 and h6 (device codes) have been corrected.Block h6: imdrf impact code f1001 captures the reportable event of procedure cancelled post-sedation.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral duodenal stent was to be implanted in the duodenum to treat stomach cancer during a procedure performed on (b)(6) 2024.During the procedure, the stent was unable to be deployed.Due to physician discretion, it was decided to terminate the procedure without placing any implant or device.Reportedly, the patient was under palliative management and passed away later on an unknown date due to reasons not related to the reported procedure.Note: a photo of the complaint device was provided by the complainant, showing that the handle was detached, and the outer sheath was kinked.

• 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: 20472235
• Report Number: 3005099803-2024-05148
• Device Sequence Number: 7471765
• Product Code: MUM
• UDI-Device Identifier: 08714729456490
• UDI-Public: 08714729456490
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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: 05/02/2026
• Device Model Number: M00565020
• Device Catalogue Number: 6502
• Device Lot Number: 0033947854
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 11/11/2024
• Date Device Manufactured: 05/02/2024
• 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: 42 YR
• Patient Sex: Male
• Patient Weight: 74 KG