BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLOCK¿-35

    MDR report key: 2328333 · Received November 8, 2011

    Report

    Report Number
    2134265-2011-04921
    Event Type
    Malfunction
    Date Received
    November 8, 2011
    Date of Event
    September 26, 2011
    Report Date
    October 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K110295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DELIVERY WIRE, INTRODUCER SHEATH, COIL, RHV, AND A NON-BSC CATHETER WERE RETURNED FOR ANALYSIS. THE COIL WAS RETURNED STUCK INSIDE THE CATHETER DUE TO DRIED BLOOD. THE CATHETER HAD TO BE CUT SEVERAL TIMES IN ORDER TO REMOVE THE COIL. UPON REMOVAL, THE COIL WAS SEVERELY STRETCHED, KINKED AND BROKEN IN TWO PLACES. THE FIRST BREAK WAS FOUND AT THE PROXIMAL END NEAR THE INTERLOCKING ARM. THE INTERLOCKING ARM WAS NOT ATTACHED TO THE COIL. THE INTERLOCKING ARM WAS FOUND IN THE CATHETER. THE SECOND BREAK WAS AT THE DISTAL END WHERE THE COIL WAS SEVERELY STRETCHED. WELD MARKS WERE PRESENT ON THE COIL AND INTERLOCKING ARM. NO ANOMALIES WERE NOTED WITH THE DELIVERY WIRE OR INTRODUCER SHEATH. THE ZAP TIP SHAPE AND SURFACE OF THE COIL AND DELIVERY WIRE WERE SMOOTH. THE DIMENSIONS THAT COULD BE MEASURED WERE FOUND TO BE IN SPECIFICATION. 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 "THE INTERLOCK - 35 FIBERED IDC OCCLUSION SYSTEM IS RECOMMENDED FOR USE WITH A 5F (0.035 IN [0.89 MM] OR 0.038 IN [0.97 MM] INNER LUMEN) IMAGER II DIAGNOSTIC CATHETER. THE USE OF OTHER DIAGNOSTIC CATHETERS MAY RESULT IN AN INABILITY TO DELIVER, DEPLOY OR RECAPTURE THE DEVICE. THE INTERLOCK- 35 FIBERED OCCLUSION SYSTEM WILL ENCOUNTER SIGNIFICANT RESISTANCE WHEN ADVANCEMENT THROUGH A SOFT WALL DELIVERY CATHETER IS ATTEMPTED." (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON 17OCT2011. IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT PROCEDURE, A COIL BECAME STUCK WITHIN A CATHETER DURING ADVANCEMENT. THE TARGET VESSEL WAS THE MILDLY TORTUOUS INTERNAL ILIAC ARTERY. ANOTHER MANUFACTURERS' 5F .038" DIAGNOSTIC CATHETER WAS ADVANCED TO THE TARGET AREA. A 15MMX40CM INTERLOCK .035 COIL WAS ADVANCED INTO THE CATHETER WITH THE USE OF CONTINUOUS FLUSH. DURING ADVANCEMENT, THE COIL BECAME STUCK IN THE PROXIMAL TO MID SECTION OF THE CATHETER AND DETACHED PREMATURELY FROM THE DELIVERY WIRE. THE CATHETER WITH COIL WAS REMOVED FROM THE PATIENT. THE COIL WAS REMOVED FROM THE CATHETER ONCE OUTSIDE THE PATIENT AND THE SAME CATHETER WAS REINTRODUCED. THIS 15MMX40CM INTERLOCK .035 COIL WAS THEN ADVANCED INTO THE CATHETER WHEN IT ALSO DETACHED PREMATURELY FROM THE DELIVERY WIRE. THE CATHETER WITH COIL WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT NON-BSC CATHETER AND NON-BSC COILS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE COIL AND COIL INTERLOCKING ARM WERE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLOCK¿-35 DEVICE, EMBOLIZATION, VASCULAR KRD BOSTON SCIENTIFIC - CORK M001363820 14476924

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR 5F .038 COOK DIAGNOSTIC CATHETER