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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 Entrapment of Device (1212)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/02/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the coil protruded from the catheter's tip during removal.A 3mmx12cm interlock coil was selected for use in a severely tortuous vessel.During procedure, the coil became stuck in the distal part of the catheter.Furthermore, when the coil was removed from the patient's body, it was noted that the coil protruded from the tip of the microcatheter.Only the coil was removed as it was and the procedure was completed with another of the same device.No patient complications were reported and patient 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 Key10148349
Report Number2134265-2020-07904
Device Sequence Number2176824
Product Code KRD
UDI-Device Identifier08714729764946
UDI-Public08714729764946
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,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/12/2020
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 Date10/14/2022
Device Model Number83779
Device Catalogue Number83779
Device Lot Number0024767798
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/02/2020
Initial Report FDA Received Date06/12/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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