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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 Premature Activation (1484); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/25/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(6).
 
Event or Problem Description
It was reported that coil protrusion during removal occurred.The lesion was in the inferior mesenteric artery.A 2mmx6cm interlock was selected for use.During procedure, the coil detached inside the microcatheter as the main coil and arm of the delivery wire got separated.Subsequently, the coil was removed together with the microcatheter and was noted protruding from the catheter's tip.The procedure was completed with another of the same device.No complications were reported and patient condition was good post procedure.
 
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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 Key9437446
Report Number2134265-2019-15241
Device Sequence Number13511558
Product Code KRD
UDI-Device Identifier08714729845270
UDI-Public08714729845270
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 Other Health Care Professional
Type of Report Initial
Report Date (Section B) 12/09/2019
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 Date03/10/2021
Device Model Number83779
Device Catalogue Number83779
Device Lot Number0021969460
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/26/2019
Initial Report FDA Received Date12/09/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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