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

Model Number M00555780

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a150207 captures the reportable event of the delivery system difficult to remove.

Event 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
• Type of Device: 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
• MDR Text Key: 321722848
• Report Number: 3005099803-2023-04511
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 08714729902607
• UDI-Public: 08714729902607
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K200257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1