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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
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BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION Back to Search Results
Model Number 83786
Medical Device Problem Code Entrapment of Device (1212)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/26/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(6).
 
Event or Problem Description
It was reported that coil protruded from the catheter tip.The target lesion area was located in a moderately tortuous internal iliac artery.A 10mm x 20cm interlock-35 embolic was selected for use in the embolization of an aneurysm in the internal iliac artery.During the procedure, the coil got stuck inside the catheter at the distal part.However, the coil protruded from the catheter tip upon removal.The coil was removed as it was.The procedure was completed with another of the same device.No patient complications reported.
 
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Brand Name
INTERLOCK-35
Common Device Name
DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10949545
Report Number2134265-2020-16897
Device Sequence Number3317691
Product Code KRD
UDI-Device Identifier08714729793137
UDI-Public08714729793137
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K133208
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) 12/04/2020
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 Date05/20/2023
Device Model Number83786
Device Catalogue Number83786
Device Lot Number0025525849
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/26/2020
Initial Report FDA Received Date12/04/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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