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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION ULTRAFLEX ESOPHAGEAL NG; PROSTHESIS, ESOPHAGEAL Back to Search Results
Model Number M00514250
Device Problems Break (1069); Human-Device Interface Problem (2949); Device Stenosis (4066)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/11/2023
Event Type  Injury  
Event Description
It was reported to boston scientific corporation that an ultraflex esophageal proximal release covered stent was implanted in the esophagus for the treatment of a 2cm stenosis due to esophageal cancer during a gastroscopy procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was not dilated prior to stent placement.On (b)(6) 2023, it was observed that the stent's distal end had overgrowth.The stent was moved slightly distally using rat tooth grasping forceps.During the procedure, it was also noted that the stent was obstructed by a small amount of food.The physician pushed past some impacted food and found that the stent had broken into two pieces.The patient was referred to a different hospital for stent removal and placement of a new stent.No patient complications were reported as a result of this event.
 
Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent break.Imdrf device code a22 captures the reportable event of stent overgrowth.Imdrf device code a0106 captures the reportable event of stent obstruction.Imdrf patient code e2008 captures the reportable event of unretrieved device fragment.Imdrf impact code f23 captures the reportable event of additional intervention performed to adjust the position of the stent.
 
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Brand Name
ULTRAFLEX ESOPHAGEAL NG
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 Key18501852
MDR Text Key332761911
Report Number3005099803-2023-06950
Device Sequence Number1
Product Code ESW
UDI-Device Identifier08714729716112
UDI-Public08714729716112
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K091816
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 01/12/2024
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 Model NumberM00514250
Device Catalogue Number1425
Device Lot Number0031373096
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/20/2023
Initial Date FDA Received01/12/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/05/2023
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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