BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDC?

    MDR report key: 3180405 · Received June 20, 2013

    Report

    Report Number
    2134265-2013-04505
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K040342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED: DEVICE EVALUATED BY MANUFACTURER: IT WAS ORIGINALLY REPORTED THAT THE ROOT CAUSE WAS USER RELATED AS IT WAS REPORTED THAT THE DELIVERY WIRE WAS ROTATED MORE THAN 360 DEGREES DURING DELIVERY. HOWEVER, IT WAS FURTHER REPORTED THAT THE DELIVERY WIRE WAS NOT ROTATED MORE THAN 360 DEGREES DURING DELIVERY. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT THE TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS USER-RELATED AS THE DFU STATES: ¿DO NOT ROTATE THE DELIVERY WIRE MORE THAN ONE TURN (360 DEGREES) DURING DELIVERY OF THE IDC COIL. EXCESSIVE ROTATION OF THE DELIVERY WIRE MAY DAMAGE THE COIL OR MAY RESULT IN PREMATURE DETACHMENT OF THE INTERLOCKING ARMS WITHIN THE MICROCATHETER.¿ (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE, A COIL WAS PROTRUDING FROM THE MICROCATHETER. THE TARGET LESION WAS LOCATED THE MODERATELY TORTUOUS INTERNAL ILIAC ARTERY. A 5MM X 12CM IDC-18 SOFT DETACHABLE COIL WAS SELECTED AND ADVANCED TO TREAT THE TARGET LESION. CONTINUOUS FLUSH WAS PERFORMED. DURING INSERTION OF THE COIL, IT WAS NOTED THAT THE INTERLOCK SECTION WAS DETACHED AT THE PROXIMAL HUB OF THE MICROCATHETER. DIFFICULTY DELIVERING THE DEVICE WAS THEN NOTED. THE DEVICE WAS ADVANCED; HOWEVER, IT GOT STUCK. REMOVAL OF THE COIL WAS ATTEMPTED BUT IT COULD NOT BE REMOVED. THE COIL WAS THEN REMOVED TOGETHER WITH THE MICROCATHETER. UPON REMOVAL, IT WAS THEN NOTED THAT PART OF THE COIL WAS STILL PROTRUDING FROM THE TIP OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE, A COIL WAS PROTRUDING FROM THE MICROCATHETER. THE TARGET LESION WAS LOCATED THE MODERATELY TORTUOUS INTERNAL ILIAC ARTERY. A 5MM X 12CM IDC-18 SOFT DETACHABLE COIL WAS SELECTED AND ADVANCED TO TREAT THE TARGET LESION. CONTINUOUS FLUSH WAS PERFORMED. DURING INSERTION OF THE COIL, IT WAS NOTED THAT THE INTERLOCK SECTION WAS DETACHED AT THE PROXIMAL HUB OF THE MICROCATHETER. DIFFICULTY DELIVERING THE DEVICE WAS THEN NOTED. THE DEVICE WAS ADVANCED; HOWEVER, IT GOT STUCK. REMOVAL OF THE COIL WAS ATTEMPTED BUT IT COULD NOT BE REMOVED. THE COIL WAS THEN REMOVED TOGETHER WITH THE MICROCATHETER. UPON REMOVAL, IT WAS THEN NOTED THAT PART OF THE COIL WAS STILL PROTRUDING FROM THE TIP OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280547 IDC? DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC - CORK M0013615120 15453186

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: 6F25CM SHEATH / MEDIKIT| GUIDING CATHETER: VS CATHETER 5F / COOK| MICRO CATHETER: RENEGADE2M / STRYKER