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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 Break (1069); Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/21/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the delivery wire got broken.The target lesion area was located in a moderately tortuous right femoral artery.A 14mmx50cm interlock embolic was selected for use in a coil embolization.During the procedure, it was noted that the device got stuck inside the microcatheter and could not advance.However, the delivery wire got broken/kinked.The device was removed together with the microcatheter.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 Key10762688
Report Number2134265-2020-15001
Device Sequence Number3261675
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) 10/30/2020
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 Date01/05/2023
Device Model Number83779
Device Catalogue Number83779
Device Lot Number0025160173
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/21/2020
Initial Report FDA Received Date10/30/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
GUIDEWIRE-FATHOM; MICRO CATHETER-BREAKTHROUGH 2M
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