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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM; PANCREATIC STENT, COVERED, METALLIC, REMOVABLE

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BOSTON SCIENTIFIC CORPORATION AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM; PANCREATIC STENT, COVERED, METALLIC, REMOVABLE Back to Search Results
Model Number M00553570
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 02/13/2023
Event Type  Injury  
Manufacturer Narrative
Initial reporter facility name, address, and phone number: (b)(6).Imdrf patient code e0506 captures the reportable patient complication of bleeding.Impact code f08 captures additional hospitalization to monitor patient's condition due to bleeding.
 
Event Description
It was reported to boston scientific corporation on march 13,2023 that an axios stent and electrocautery enhanced delivery system was to be implanted transgastric to pancreas to treat a walled-off-necrosis (won) during an endosonography procedure performed on (b)(6) 2023.During the procedure.Bleeding was noted in the stomach after stent placement.The axios stent was removed from the patient with forceps, and the procedure was completed.The walled-off-necrosis was drained through the puncture site and the size has been reduced.The patient was monitored in the (imc) intermediate care unit for one night due to bleeding.On (b)(6) 2023, the patient was discharged.
 
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Brand Name
AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
Type of Device
PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
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 Key16708757
MDR Text Key312973588
Report Number3005099803-2023-01905
Device Sequence Number1
Product Code PCU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K220112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/10/2023
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? No
Device Operator Health Professional
Device Model NumberM00553570
Device Catalogue Number5357
Device Lot Number0029825355
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/13/2023
Initial Date FDA Received04/10/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/25/2022
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 Outcome(s) Hospitalization;
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