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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EPIC VASCULAR; STENT, ILIAC
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BOSTON SCIENTIFIC CORPORATION EPIC VASCULAR; STENT, ILIAC Back to Search Results
Model Number 39200
Device Problems Tear, Rip or Hole in Device Packaging (2385); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/26/2023
Event Type  malfunction  
Event Description
It was reported that device contamination occurred.A 10x40x75 epic vascular stent was selected for use.However, when the shipping box was opened, it was noticed that the inner pouch has a hole and the device inside was bent.No patient complications were reported.
 
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Brand Name
EPIC VASCULAR
Type of Device
STENT, ILIAC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key16387397
MDR Text Key309675692
Report Number2124215-2023-04579
Device Sequence Number1
Product Code NIO
UDI-Device Identifier08714729805014
UDI-Public08714729805014
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/16/2023
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 Number39200
Device Catalogue Number39200
Device Lot Number0030743620
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/26/2023
Initial Date FDA Received02/16/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/20/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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