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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IDC; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
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BOSTON SCIENTIFIC CORPORATION IDC; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION Back to Search Results
Model Number 83775
Medical Device Problem Codes Premature Activation (1484); Malposition of Device (2616)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/03/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the coil was not placed within the target lesion.A 4mmx12cm idc embolic coil was selected for use in a chemo embolization of the liver procedure.The 4mmx12cm idc embolic coil was advanced through the renegade catheter and deployed prematurely not within the intended target location of the liver.The procedure was completed with a different device.No further patient complications were reported.
 
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Brand Name
IDC
Common Device Name
DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11554622
Report Number2134265-2021-03497
Device Sequence Number4047946
Product Code KRD
UDI-Device Identifier08714729158752
UDI-Public08714729158752
Combination Product (Y/N)N
Initial Reporter StateOR
Initial Reporter CountryUS
PMA/510(K) Number
K141378
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/23/2021
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
Operator of Device Health Professional
Device Expiration Date03/25/2022
Device Model Number83775
Device Catalogue Number83775
Device Lot Number0023694915
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/04/2021
Initial Report FDA Received Date03/23/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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