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

Model Number	M00565050
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block e1: initial reporter's facility name is (b)(6); reported here as the facility name exceeded character limit for designated field.Block h6: imdrf device code a150103 captures the reportable event of stent premature deployment.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral colonic stent was implanted in the colon to treat a 4cm malignant tumor during a stent placement procedure performed on (b)(6) 2024.The patient's anatomy was tortuous.During the procedure, when the stent was deployed, the anterior portion of the stent could not be deployed.Subsequently, the stent's delivery system was adjusted, and the stent was deployed continuously; however, the stent suddenly slipped and was deployed inside the patient.Both snares and forceps were used multiple times in an attempt to remove the stent, but it was unable to be removed.Another wallflex enteral colonic stent was used to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.

• Brand Name: WALLFLEX COLONIC
• 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: 20170823
• Report Number: 3005099803-2024-04421
• Device Sequence Number: 17893261
• Product Code: MQR
• UDI-Device Identifier: 08714729456520
• UDI-Public: 08714729456520
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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
• Report Date (Section B): 09/09/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/24/2025
• Device Model Number: M00565050
• Device Catalogue Number: 6505
• Device Lot Number: 0031490811
• 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: 08/16/2024
• Initial Report FDA Received Date: 09/09/2024
• Date Device Manufactured: 04/25/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown