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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 Stretched (1601); Migration (4003)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 11/17/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported the coil came out of the target vessel.A 4mm x 8cm idc was selected for use in a severely tortuous vessel.After the coil was placed into the lesion, the detached pusher wire became caught in the placed coil.The coil became unraveled while pushing/pulling it several times.The coil was not placed properly and came out of the target vessel.There were no patient complications 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 Key8162619
Report Number2134265-2018-64032
Device Sequence Number1825931
Product Code KRD
UDI-Device Identifier08714729158745
UDI-Public08714729158745
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K141378
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/13/2018
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
Operator of Device Health Professional
Device Expiration Date12/11/2020
Device Model Number83775
Device Catalogue Number83775
Device Lot Number0021601455
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/20/2018
Initial Report FDA Received Date12/13/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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