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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 12/10/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the coil was stuck in the catheter's tip during removal.The target lesion was located in the internal iliac artery.A 14mm x 50cm interlock coil was selected for use.During the procedure, it was noted that the coil was stuck on the distal part of the microcatheter.The device was removed normally; however, during removal, it was noted that the coil protruded from the catheter's tip.The procedure was completed with another of the same device.There were no patient complications 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 Key9527353
Report Number2134265-2019-16129
Device Sequence Number11438767
Product Code KRD
UDI-Device Identifier08714729845294
UDI-Public08714729845294
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) 12/27/2019
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 Date05/27/2021
Device Model Number83779
Device Catalogue Number83779
Device Lot Number0022306491
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/11/2019
Initial Report FDA Received Date12/27/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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