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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 09/14/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Initial reporter city: (b)(6).
 
Event or Problem Description
It was reported that the coil protruded from the catheter's tip during removal.The target lesion was located in the left internal iliac artery.A 10mmx50cm interlock coil was selected for use.During procedure, it was noted that the coil became stuck in the distal part of the catheter.Furthermore, when the coil was removed from the patient's body, it was noted that the coil protruded from the tip of the microcatheter.The coil was removed together with the catheter and 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 Key10593733
Report Number2134265-2020-13367
Device Sequence Number3735369
Product Code KRD
UDI-Device Identifier08714729845287
UDI-Public08714729845287
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) 09/28/2020
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 Date04/05/2023
Device Model Number83779
Device Catalogue Number83779
Device Lot Number0025491268
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/15/2020
Initial Report FDA Received Date09/28/2020
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
GUIDE CATHETER: 5F ANGIOGRAPHIC CATHETER; GUIDEWIRE: TREASURE FLOPPY; INTRODUCER SHEATH: 5F SHEATH; MICRO CATHETER: BREAKTHROUGH2M
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