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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX ESOPHAGEAL; PROSTHESIS, ESOPHAGEAL

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BOSTON SCIENTIFIC CORPORATION WALLFLEX ESOPHAGEAL; PROSTHESIS, ESOPHAGEAL Back to Search Results
Model Number M00516210
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/08/2024
Event Type  Injury  
Manufacturer Narrative
Imdrf device code a0401 captures the reportable event of a stent's suture break.
 
Event Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered rmv stent was to be implanted in the esophagus to treat a benign stricture during a gastroscopy procedure performed on (b)(6) 2024.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent was intended to be repositioned, but when the doctor grabbed the suture using rat-tooth forceps, the suture broke, and the doctor could not grab anything to change the position of the stent.The stent was removed from the patient using rat-tooth forceps, and the procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
 
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Brand Name
WALLFLEX ESOPHAGEAL
Type of Device
PROSTHESIS, ESOPHAGEAL
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 Key18631116
MDR Text Key334434601
Report Number3005099803-2024-00254
Device Sequence Number1
Product Code ESW
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K091510
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/02/2024
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
Device Operator Health Professional
Device Expiration Date12/24/2022
Device Model NumberM00516210
Device Catalogue Number1621
Device Lot Number0027558101
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/08/2024
Initial Date FDA Received02/02/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/25/2021
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 Outcome(s) Required Intervention;
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