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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 Codes Separation Failure (2547); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/24/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that there was coil protrusion from the catheter's tip during removal.A 3mm x 6cm 2d f-idc interlock was selected for use.During the procedure, it was noted that the coil failed to release.Furthermore, during removal of the device, the coil protruded from the catheter's tip.The procedure was completed with different device.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 Key7783107
Report Number2134265-2018-60093
Device Sequence Number1011540
Product Code KRD
UDI-Device Identifier08714729764939
UDI-Public08714729764939
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K132578
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/14/2018
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 Date01/31/2020
Device Model Number83779
Device Catalogue Number83779
Device Lot Number0020242906
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/25/2018
Initial Report FDA Received Date08/14/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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