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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 83787
Medical Device Problem Codes Break (1069); Separation Failure (2547)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/10/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the guidewire broke off.A 8mm x 20cm interlock cube was selected for embolization of the target lesion.The coil was inserted through a 4f angiography catheter and there was difficulty to detach the pusher wire from the coil after the coil was deployed within the lesion.Subsequently, the pusher wire broke, the physician was able to withdraw the pusher wire through the catheter.No device fragments were left within the patient.The procedure was completed with another of the same device.No complications reported and patient is stable.
 
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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 Key8285556
Report Number2134265-2019-00507
Device Sequence Number11184077
Product Code KRD
UDI-Device Identifier08714729793052
UDI-Public08714729793052
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K133208
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) 01/29/2019
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 Date01/31/2020
Device Model Number83787
Device Catalogue Number83787
Device Lot Number0020137974
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/09/2019
Initial Report FDA Received Date01/29/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age48 YR
Patient Weight79
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