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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
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BOSTON SCIENTIFIC CORPORATION INTERLOCK; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION Back to Search Results
Model Number 83779
Medical Device Problem Code Premature Activation (1484)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 06/03/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported via medwatch (b)(4) that the coil detached before being placed in the desired location.A 3mmx6cm interlock was selected for use in a vascular embolization procedure.During the procedure, the coil detached before being placed in the desired location.No patient complications were reported.
 
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Brand Name
INTERLOCK
Common Device Name
DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11931331
Report Number2134265-2021-07163
Device Sequence Number19955974
Product Code KRD
UDI-Device Identifier08714729764939
UDI-Public08714729764939
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K132578
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 06/03/2021
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 Date12/25/2021
Device Model Number83779
Device Catalogue Number83779
Device Lot Number0023243395
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/13/2021
Initial Report FDA Received Date06/03/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age66 YR
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