MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX COLONIC SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM; STENT, COLONIC, METALIC, EXPANDABLE

Model Number	M00555780
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a150207 captures the reportable event of the delivery system difficult to remove.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2023, that a wallflex enteral colonic uncovered stent was to be implanted in the hepatic flexure biliary to treat a stricture during a colonic stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tight.During the procedure, the stent was successfully deployed; however, the delivery system was difficult to remove as it seemed to get stuck.The surgeon cut the sheath from the handle and pulled it out.The stent remains implanted, and the procedure was completed.There were no patient complications reported as a result of this event.

• Brand Name: WALLFLEX COLONIC SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM
• Common Device Name: STENT, COLONIC, METALIC, EXPANDABLE
• 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: 17602287
• Report Number: 3005099803-2023-04511
• Device Sequence Number: 6125890
• Product Code: MQR
• UDI-Device Identifier: 08714729902607
• UDI-Public: 08714729902607
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K200257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 08/23/2023

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: 06/05/2025
• Device Model Number: M00555780
• Device Catalogue Number: 5578
• Device Lot Number: 0031758894
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2023
• 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 Sex: Unknown