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

Model Number M00565040

Device Problem Premature Activation (1484)

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

Event Date 02/21/2024

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a150103 captures the reportable event of a premature stent deployment.

Event Description

It was reported to boston scientific corporation that a wallflex enteral colonic stent was implanted in the colon to treat a malignant 4 cm neoplastic colon stenosis during a stent placement procedure performed on (b)(6), 2024.During the procedure, the stent came out too quickly when the delivery catheter was retracted.Fortunately, the stent was deployed in the correct location, and no intervention was required.There were no patient complications reported as a result of this event, and the patient's condition after the procedure was reported to be stable.

• 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: 18921855
• MDR Text Key: 337875533
• Report Number: 3005099803-2024-01011
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 08714729456513
• UDI-Public: 08714729456513
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K061877
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2024

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
• Device Operator: Health Professional
• Device Model Number: M00565040
• Device Catalogue Number: 6504
• Device Lot Number: 0032629642
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2023
• 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