BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERLOCK?-35

    MDR report key: 3133523 · Received May 29, 2013

    Report

    Report Number
    2134265-2013-03492
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 27, 2013
    Report Date
    May 1, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K110295
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS RELATED TO USER ISSUES, AS THE DIRECTIONS FOR USE INDICATED TO MAINTAIN CONTINUOUS FLUSH TO SUCCESSFULLY DEPLOY COIL. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PROCEDURE, PREMATURE COIL DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE PORTAL HEPATIC VEIN. A .035 INTERLOCK 2D 8MM X 40CM COIL DISLODGED PREMATURELY IN AN UNKNOWN MANUFACTURER¿S CATHETER THEN A .035 INTERLOCK 10MM X 40CM WAS NOT ABLE TO BE PLACED ACCURATELY AND THIS COIL DISLODGED IN THE PATIENT. IT WAS NOTED THAT CONTINUOUS FLUSH WAS NOT USED. THE DISLODGED COIL WAS SUCCESSFULLY SNARED OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE USING CONTINUOUS FLUSH. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235574 INTERLOCK?-35 DEVICE, EMBOLIZATION, VASCULAR KRD BOSTON SCIENTIFIC - CORK M001363800 0015656674

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention