MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX COLONIC; STENT, COLONIC, METALIC, EXPANDABLE

Model Number M00565050

Device Problems Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Material Deformation (2976); Positioning Problem (3009)

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

Event Date 10/02/2023

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf device code a150207 captures the reportable event of stent difficult to remove.Imdrf device code a0406 captures the reportable event of stent material deformation.

Event Description

It was reported to boston scientific corporation that a wallflex enteral colonic stent was implanted in the colon to treat a malignant stricture during a sigmoidoscopy with stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous.During the procedure, there was difficulty in deploying the stent.The stent was eventually deployed but it was deployed in an incorrect location.Subsequently, the stent was attempted to be removed with forceps; however, the retrieval loop straightened out and the stent could no longer be removed.A longer wallflex enteral stent was placed stent-in-stent to complete the procedure.There were no patient complications reported as a result of this event.

• Brand Name: WALLFLEX COLONIC
• 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: 18021164
• MDR Text Key: 326794142
• Report Number: 3005099803-2023-05650
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 08714729456520
• UDI-Public: 08714729456520
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061877
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2023
• Device Model Number: M00565050
• Device Catalogue Number: 6505
• Device Lot Number: 0028575581
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2023
• Initial Date FDA Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2021
• 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
• Patient Outcome(s): Required Intervention