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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EPIC; STENT, ILIAC
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BOSTON SCIENTIFIC CORPORATION EPIC; STENT, ILIAC Back to Search Results
Model Number 20300
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/26/2021
Event Type  malfunction  
Event Description
It was reported that foreign material was noted on the device.During preparation of a 10x100x120 epic stent, the physician noted a glue-like material in the delivery system.The procedure was completed with a different device.No patient complications were reported.
 
Event Description
It was reported that foreign material was noted on the device.During preparation of a 10x100x120 epic stent, the physician noted a glue-like material in the delivery system.The procedure was completed with a different device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an epic self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the pouch is bent in half.The device was taken out of the pouch to be inspected.The sheath is kinked 85cm from the tip.The sheath is damaged 17cm from the tip.The sheath is pulled out of the nosecone.Microscopic examination revealed no additional damages.The rack is inside the handle and the lock is missing.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found that the device appears to have been used and damaged which would contribute to the reported glue-like substance seen on the device.
 
Manufacturer Narrative
(d4) lot number: updated to 0026258299.(d4) expiration date: updated to 10/27/2023.(d4) unique identifier (udi) #: updated to (b)(4).(g1) mfr site facility name: updated from boston scientific ireland limited to boston scientific corporation (g1) mfr site address 1: updated to ballybrit business park (h4) device manufacture date: 10/27/2020 device evaluated by mfr: returned product consisted of an epic self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the pouch is bent in half.The device was taken out of the pouch to be inspected.The sheath is kinked 85cm from the tip.The sheath is damaged 17cm from the tip.The sheath is pulled out of the nosecone.Microscopic examination revealed no additional damages.The rack is inside the handle and the lock is missing.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found that the device appears to have been used and damaged which would contribute to the reported glue-like substance seen on the device.
 
Event Description
It was reported that foreign material was noted on the device.During preparation of a 10x100x120 epic stent, the physician noted a glue-like material in the delivery system.The procedure was completed with a different device.No patient complications were reported.
 
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Brand Name
EPIC
Type of Device
STENT, ILIAC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11851899
MDR Text Key251672903
Report Number2134265-2021-06187
Device Sequence Number1
Product Code NIO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup,Followup
Report Date 07/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/27/2023
Device Model Number20300
Device Catalogue Number20300
Device Lot Number0026258299
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2021
Date Manufacturer Received07/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age56 YR
Patient Weight67
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