Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION Back to Search Results
Model Number 83786
Medical Device Problem Code Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 04/13/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the coil protrudes from the catheter tip.Vascular access was obtained via ipsilateral approach.The target lesion was located in the severely tortuous internal iliac artery.Three interlock-35 coils (10mmx40cm, 12mm x 40cm, 4mm x 10cm) were selected for use.During the procedure, it was noted that the devices got stuck in the distal part of the 5fr imager catheter.The devices were then removed together however the coil protruded from the catheter's tip upon removal.The procedure was completed with another of the same device.There were no patient complications reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10016999
Report Number2134265-2020-05861
Device Sequence Number16696472
Product Code KRD
UDI-Device Identifier08714729792987
UDI-Public08714729792987
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) 05/01/2020
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 Date05/15/2022
Device Model Number83786
Device Catalogue Number83786
Device Lot Number0023800957
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/14/2020
Initial Report FDA Received Date05/01/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-