Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX COLONIC; STENT, COLONIC, METALIC, EXPANDABLE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION WALLFLEX COLONIC; STENT, COLONIC, METALIC, EXPANDABLE Back to Search Results
Model Number M00565050
Device Problems Break (1069); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/21/2023
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a wallflex enteral colonic stent was to be implanted in the sigmoid colon to treat an intestinal obstruction due to intestinal cancer during an intestinal stent implantation procedure performed on (b)(6) 2023.During the procedure, the stent could not be deployed despite completely pulling the handle.The stent was removed from the patient partially deployed on the delivery system, and the stent wires were broken.The procedure was not completed, and the patient was rescheduled for a radical resection of the colon later that day to treat the patient's underlying condition of cancer.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.
 
Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent break.
 
Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent break.Block h10: the wallflex enteral colonic stent and delivery system were received for analysis.Visual inspection found that the stent was partially deployed on the delivery system, and the wires of the stent were broken.The outer sheath was kinked in different sections, and the stainless-steel handle was bent.Functional inspection was performed by sliding the handle back along the stainless-steel tube, and the stent was deployed without resistance.Media inspection showed that the stent was partially deployed and broken.No other damages were noted with the stent or the delivery system.Product analysis confirmed the reported events of the stent being partially deployed and the stent being broken.The investigation concluded that the reported events and the additional investigation findings of sheath kinked and stainless-steel shaft kinked were most likely caused by procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied) that could have resulted in the damages found in the device.Therefore, a review and analysis of all available information indicated that the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.
 
Event Description
It was reported to boston scientific corporation that a wallflex enteral colonic stent was to be implanted in the sigmoid colon to treat an intestinal obstruction due to intestinal cancer during an intestinal stent implantation procedure performed on (b)(6) 2023.During the procedure, the stent could not be deployed despite completely pulling the handle.The stent was removed from the patient partially deployed on the delivery system, and the stent wires were broken.The procedure was not completed, and the patient was rescheduled for a radical resection of the colon later that day to treat the patient's underlying condition of cancer.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key17859735
MDR Text Key324774739
Report Number3005099803-2023-05302
Device Sequence Number1
Product Code MQR
UDI-Device Identifier08714729456520
UDI-Public08714729456520
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K061877
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/17/2023
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 NumberM00565050
Device Catalogue Number6505
Device Lot Number0029632504
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/14/2023
Initial Date FDA Received10/03/2023
Supplement Dates Manufacturer Received11/01/2023
Supplement Dates FDA Received11/17/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/22/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age53 YR
Patient SexMale
Patient Weight60 KG
-
-