BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERLOCK¿-35

    MDR report key: 2991119 · Received March 6, 2013

    Report

    Report Number
    2134265-2013-01322
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K110295
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS DETERMINED TO BE USER RELATED AS AN INCOMPATIBLE CATHETER WAS USED AND INSUFFICIENT FLUSH WAS MAINTAINED DURING THE PROCEDURE. THE DFU STATES THAT ("AN IMAGER II SELECTIVE DIAGNOSTIC CATHETER IS TO BE USED IN CONJUNCTION WITH THE 035 COIL"; AND "USE CONTINUOUS FLUSH BEFORE INTRODUCING THE COIL INTO THE CATHETER"). (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2013-01321. IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT PROCEDURE, TWO COILS PROTRUDED FROM CATHETER. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS INTERNAL ILIAC ARTERY. FOLLOWING A STENT PLACEMENT, AN EMBOLIZATION OF THE RIGHT HYPOGASTRIC OCCURRED. FOUR COILS WERE USED WITH INTERMITTENT FLUSH IN A NON-BSC CATHETER. THE 1ST AND 3RD COILS WERE DELIVERED SUCCESSFULLY AND THE 2ND AND 4TH COILS WERE REPORTED AS PROTRUDING FROM END OF CATHETER. THE 2ND COIL USED WAS AN 8 MM X 20 CM .035 INTERLOCK 2D COIL WHICH WAS UNABLE TO CROSS INTO THE HYPOGASTRIC AND BECAME STUCK IN THE CATHETER, PARTIALLY PROTRUDING OUT OF THE CATHETER. THE 2ND COIL WAS SNARED OUT SUCCESSFULLY. THE 4TH COIL USED WAS A 6 MM X 10 CM .035 INTERLOCK 2D COIL WHICH WAS DIFFICULT TO ADVANCE BUT ONCE IT REACHED THE TARGET LESION, THE COIL "FLIPPED OUT" AND WAS PARTIALLY PROTRUDING FROM END OF CATHETER. THIS COIL WAS ALSO SNARED OUT SUCCESSFULLY. IT WAS NOTED THAT THE PHYSICIAN REALIZED THEY SHOULD HAVE USED CONTINOUS FLUSH WHEN DELIVERING THE COILS. THE PROCEDURE WAS CONTINUED WITH MORE OF THE SAME .035 INTERLOCK COILS USING CONTINUOUS FLOW. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95838 INTERLOCK¿-35 DEVICE, EMBOLIZATION, VASCULAR KRD BOSTON SCIENTIFIC - CORK M001363580 15548817

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER: BERENSTEIN (COOK)