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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 05/11/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the coil protruded in the catheter's tip during removal.The target lesion was located in the moderately tortuous inferior mesenteric artery.A 3mmx4cm interlock-35 coil was selected for use.During the procedure, it was noted that the coil became stuck in the distal part of the 5f non bsc catheter.Furthermore, when the coil was removed from the patient's body, it was noted that the coil protruded from the tip of the catheter.The procedure was completed with another of the same device.No complications were reported and the 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 Key10079752
Report Number2134265-2020-06818
Device Sequence Number11490830
Product Code KRD
UDI-Device Identifier08714729793151
UDI-Public08714729793151
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) 05/21/2020
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 Date11/27/2020
Device Model Number83786
Device Catalogue Number83786
Device Lot Number0021438951
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/12/2020
Initial Report FDA Received Date05/21/2020
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
CATHETER - IMPRESS 5F
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