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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
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BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION Back to Search Results
Model Number 83786
Medical Device Problem Codes Entrapment of Device (1212); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/04/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(6).
 
Event or Problem Description
It was reported that coil protrusion occurred.The target lesion was located in the inferior mesenteric artery.A 3mmx4cm interlock-35 was selected for use.During procedure, the coil became stuck in the distal part of a non-bsc microcatheter and was then removed as usual.However, the coil was noted protruding from the catheter's tip upon removal.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-35
Common Device Name
DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9459919
Report Number2134265-2019-15583
Device Sequence Number13992986
Product Code KRD
UDI-Device Identifier08714729793151
UDI-Public08714729793151
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K133208
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) 12/12/2019
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 Date11/08/2021
Device Model Number83786
Device Catalogue Number83786
Device Lot Number0022914649
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/05/2019
Initial Report FDA Received Date12/12/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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