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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 Codes Entrapment of Device (1212); Premature Activation (1484)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/26/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(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 moderately tortuous and non calcified subclavian artery.A 12mm x 20cm interlock -35 coil was selected for use.During procedure, it was noted that the coil detached prematurely inside the microcatheter.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 microcatheter and the procedure was completed with another of the same device.No patient complications were reported and patient was good post procedure.
 
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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 Key10133846
Report Number2134265-2020-07702
Device Sequence Number3815986
Product Code KRD
UDI-Device Identifier08714729793175
UDI-Public08714729793175
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) 06/09/2020
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 Date06/19/2022
Device Model Number83786
Device Catalogue Number83786
Device Lot Number0023983190
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/29/2020
Initial Report FDA Received Date06/09/2020
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
GUIDEWIRE: RADIFOCUS; MICROCATHETER: PYTHON
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