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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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/03/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the coil protruded from the catheter tip during removal.The target lesion was located in the mildly tortuous internal iliac artery.A 18mm x 50cm interlock coil was selected for use in an abdominal aortic aneurysm.During the procedure, the coil could not advance any further than 20cm into the blood vessel.Consequently, the device was pulled out and it was noted that the coil was protruding from the catheter tip.The procedure was completed with a different device.No patient complications were 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 Key12361710
Report Number2134265-2021-10348
Device Sequence Number3794932
Product Code KRD
UDI-Device Identifier08714729845300
UDI-Public08714729845300
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K132578
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/24/2021
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 Date04/13/2024
Device Model Number83779
Device Catalogue Number83779
Device Lot Number0027315192
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/03/2021
Initial Report FDA Received Date08/24/2021
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
MICROCATHETER: BREAKTHROUGH2 MARKER
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