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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 Premature Activation (1484); Difficult to Remove (1528)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 11/01/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Date of event is an estimated date based off the aware date as the exact event date was not reported.
 
Event or Problem Description
It was reported that the coil was difficult to remove and was snared.A 5mm x 15cm interlock coil was selected for use.During the procedure, it was noted that the coil was detached inside the renegade stc catheter and was unable to be removed from inside the patient.The coil was removed with a snare.No further complications were reported and the patient was stable 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 Key9439518
Report Number2134265-2019-15279
Device Sequence Number2335484
Product Code KRD
UDI-Device Identifier08714729764984
UDI-Public08714729764984
Combination Product (Y/N)N
Initial Reporter StateNH
Initial Reporter CountryUS
PMA/510(K) Number
K132578
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date07/21/2021
Device Model Number83779
Device Catalogue Number83779
Device Lot Number0022541259
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/26/2019
Initial Report FDA Received Date12/09/2019
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
CATHETER: RENEGADE STC
Outcome Attributed to Adverse Event Required Intervention;
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