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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX COLONIC; STENT, COLONIC, METALIC, EXPANDABLE
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BOSTON SCIENTIFIC CORPORATION WALLFLEX COLONIC; STENT, COLONIC, METALIC, EXPANDABLE Back to Search Results
Model Number M00565080
Device Problems Break (1069); Positioning Failure (1158)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/02/2023
Event Type  malfunction  
Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: impact code f1001 is being used to capture the reportable event of cancelled or rescheduled procedure.
 
Event Description
It was reported to boston scientific corporation on (b)(6) 2023, that a wallflex enteral colonic stent was to be implanted in the colon to treat a stricture during a colonic stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tight and was not dilated prior to stent placement.During stent deployment, the stainless-steel handle broke in half, and the stent could not be deployed.The stent was removed from the patient, and the procedure was not completed because another of the same device was unavailable.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: impact code f1001 is being used to capture the reportable event of canceled or rescheduled procedure.Block h10: the wallflex enteral colonic stent and delivery system were received for analysis.A visual inspection revealed that the stent was partially deployed on the delivery system.The stainless-steel handle was separated into two sections; therefore, functional inspection was not performed.No other damage was noted to the stent or the delivery system.Product analysis confirmed the reported event of handle break.The reported event of stent failure to deploy during the procedure has also been verified as the stent was returned partially deployed on the delivery system.The investigation concluded that the reported events and the observed failure were most likely due to procedural factors.It might be lesion characteristics, handling and manipulation of the device, and the techniques used by the user (amount of force applied), limited the performance of the device and contributed to handle break and resulted in partial stent deployment.Therefore, a review and analysis of all available information indicated that the most probable cause is an 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 on (b)(6), 2023, that a wallflex enteral colonic stent was to be implanted in the colon to treat a stricture during a colonic stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tight and was not dilated prior to stent placement.During stent deployment, the stainless-steel handle broke in half, and the stent could not be deployed.The stent was removed from the patient, and the procedure was not completed because another of the same device was unavailable.There were no patient complications reported as a result of this event.
 
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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 Key17187546
MDR Text Key317917505
Report Number3005099803-2023-03333
Device Sequence Number1
Product Code MQR
UDI-Device Identifier08714729456551
UDI-Public08714729456551
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061877
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00565080
Device Catalogue Number6508
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/13/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/05/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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