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

Model Number M00565060

Device Problems Detachment of Device or Device Component (2907); Difficult to Advance (2920)

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

Event Date 06/20/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A wallflex enteral colonic stent and delivery system were received for analysis.The stent was received fully covered and undeployed.Visual inspection was performed and found one section of the inner sheath was detached from the outer sheath.The stainless steel (handle) was broken, the outer blue sheath was detached from the handle (handle break) and the outer sheath was accordioned.Functional examination could not be performed due to the condition of the returned device.No other problems were noted to the stent and delivery system.Based on the available information, the investigation concluded that the observed failures were most likely due to procedural factors encountered during the procedure.It may be that the characteristics of the lesion, handling and manipulation of the device, the techniques used by the user, and/or normal procedural difficulties encountered during the procedure limited the performance of the device.Therefore, contributing to inner sheath detachment.This type of damage could result to stent unable to be deployed.The reported event of device difficult to advance guidewire could not be confirmed.There was no confirmation on what the customer indicated due to the condition of the returned device.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.

Event Description

It was reported to boston scientific corporation that a wallflex enteral colonic stent was to be implanted to treat a malignant intestinal stenosis in the large intestine during a direct intestinal implant procedure performed on (b)(6) 2022.During the procedure, the guidewire was difficult to advance over the wallflex colonic stent delivery system.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: this event has been deemed an mdr reportable event based on investigation result which revealed the inner sheath was detached.

• 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: 15407399
• MDR Text Key: 305817803
• Report Number: 3005099803-2022-05176
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 08714729456537
• UDI-Public: 08714729456537
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: M00565060
• Device Catalogue Number: 6506
• Device Lot Number: 0027935598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2021
• 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 Age: 54 YR
• Patient Sex: Male
• Patient Weight: 50 KG