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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 Migration (4003)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/19/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that a coil migration occurred.The target lesion was located in the non tortuous internal iliac artery.A 4mm x 8cm interlock coil was selected for use.During procedure, it was noted that coil migration occurred about 2mm.The procedure was completed using 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 Key11207814
Report Number2134265-2021-00541
Device Sequence Number2191202
Product Code KRD
UDI-Device Identifier08714729764953
UDI-Public08714729764953
Combination Product (Y/N)N
Initial Reporter CountryKS
PMA/510(K) Number
K132578
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/21/2021
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 Date03/18/2022
Device Model Number83779
Device Catalogue Number83779
Device Lot Number0023665589
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/19/2021
Initial Report FDA Received Date01/21/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age82 YR
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