BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERLOCK¿

    MDR report key: 3021726 · Received March 26, 2013

    Report

    Report Number
    2134265-2013-02110
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 27, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K060078
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE A FAILURE ANALYSIS OF THE DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED USER RELATED AS THE DFU STATES: "THE INTERLOCK FIBERED IDC OCCLUSION COIL IS DESIGNED TO BE DELIVERED UNDER FLUOROSCOPY WITH A 0.021 IN (0.53 MM) INNER DIAMETER (I.D.) MICROCATHETER (E.G. RENEGADE MICROCATHETER) WITH ONE OR TWO RADIOPAQUE (RO) TIP MARKERS". (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT PROCEDURE, THE COIL DETACHED IN THE CATHETER AND DISLODGED FROM THE CATHETER DURING REMOVAL. THE PATIENT WAS UNDERGOING TREATMENT OF A LUNG ANEURYSM. AN UNKNOWN NUMBER OF COILS WERE IMPLANTED. A RENEGADE HI FLO MICRO CATHETER WAS POSITIONED IN THE PATIENT. WHILE USING THE 2/3MM X 2.3CM INTERLOCK COIL, THE INTERLOCKING ARMS DETACHED WHILE IN THE MID PORTION OF THE CATHETER. DURING REMOVAL OF THE RENEGADE WITH THE COIL INSIDE, THE GUIDE CATHETER AND INTRODUCER SHEATH WERE ALSO INADVERTENTLY WITHDRAWN. THE PHYSICIAN OPTED TO REMOVE THE GUIDE CATHETER AND SHEATH FIRST AND THEN THE RENEGADE. WHEN REMOVING THE RENEGADE FROM THE FEMORAL ACCESS SITE, THE COIL BECAME DISLODGED FROM THE CATHETER. THE COIL WAS NOTED TO BE IN THE MUSCLE, THEREFORE THE PHYSICIAN OPTED TO LEAVE IT WHERE IT WAS AND WAS NOT CONCERNED WITH ITS LOCATION. THE PROCEDURE WAS ENDED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123406 INTERLOCK¿ DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC - CORK M001361740 0015572759

    Patients

    Seq Age Sex Outcome Treatment
    1 Other