BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLOCK¿-35

    MDR report key: 2211604 · Received August 15, 2011

    Report

    Report Number
    2134265-2011-03597
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K110295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: VISUAL INSPECTION OF THE RETURNED PRODUCT REVEALED ONLY THE COIL WAS RECEIVED. THERE WAS A BLOOD PRESENT ON THE FIBERS OF THE COIL AND IT WAS NOTED TO BE STRETCHED. THERE WAS A BREAK AT THE STRETCHED SECTION AND NO INTERLOCKING ARM WAS PRESENT. MICROSCOPIC INSPECTION REVEALED THAT THE ZAP TIP SHAPE AND SURFACE OF THE COIL WERE SMOOTH. DURING DIMENSIONAL INSPECTION, 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 CONSIDERED USER RELATED AS THE DFU STATES: "DO NOT RETRACT THE INTERLOCK - 35 FIBERED IDC OCCLUSION SYSTEM TOO QUICKLY OR AGAINST RESISTANCE. DOING SO MAY RESULT IN A STRETCHED COIL OR DAMAGE TO THE INTERLOCKING MECHANISM." "THE INTERLOCK - 35 FIBERED IDC OCCLUSION SYSTEM IS DESIGNED TO BE DELIVERED UNDER FLUOROSCOPY THROUGH A 5F (0.035 IN [0.89 MM] OR 0.038 IN [0.97 MM] INNER LUMEN) IMAGER¿ II DIAGNOSTIC CATHETER." "IN ORDER TO REDUCE THE RISK OF COMPLICATIONS, A CONTINUOUS FLOW OF APPROPRIATE FLUSH SOLUTION SHOULD BE MAINTAINED THROUGH THE CATHETER AND ANY INTRALUMINAL DEVICE. CONTINUOUS FLUSHING ALSO REDUCES RETROGRADE FLOW OF BLOOD INTO THE CATHETER DURING COIL DELIVERY AND REDUCES THE POTENTIAL FOR CONTRAST CRYSTAL FORMATION AND/OR CLOTTING ON BOTH THE COIL AND INSIDE THE CATHETER LUMEN." (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT PROCEDURE, REMOVAL DIFFICULTIES WERE ENCOUNTERED AND THE COIL WAS BROKEN. THE PATIENT WAS BEING TREATED FOR A MALFORMATION OF THE PULMONARY ARTERY. A .035" NON BSC CATHETER WAS PLACED IN THE PATIENT. THE 8.0MM X 40CM .035 2D INTERLOCKING DETACHABLE COIL (IDC) WAS ADVANCED INTO THE PULMONARY ARTERY. THE COIL HAD BEEN IN THE PATIENT FOR SOME TIME AND THE PHYSICIAN OPTED TO REMOVE THE COIL UPON DETERMINING IT WAS TOO LARGE. BLOOD FLOW WAS NOTED TO BE TURBULENT AND A GREAT AMOUNT OF FORCE WAS APPLIED TO PULL THE COIL INTO THE CATHETER. DURING WITHDRAWAL, WHILE IN THE HUB OF THE CATHETER, THE COIL BROKE AT AN UNKNOWN LOCATION. AS THE COIL WAS CONTAINED WITHIN THE CATHETER, THE DEVICES WERE REMOVED TOGETHER. THE PHYSICIAN NOTED THAT THE BREAK WAS LIKELY CAUSED BY TOO MUCH FORCE DURING WITHDRAWAL IN A SOFT CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT PROCEDURE, REMOVAL DIFFICULTIES WERE ENCOUNTERED AND THE COIL WAS BROKEN. THE PATIENT WAS BEING TREATED FOR A MALFORMATION OF THE PULMONARY ARTERY. A .035" NON BSC CATHETER WAS PLACED IN THE PATIENT. THE 8.0MM X 40CM .035 2D INTERLOCKING DETACHABLE COIL (IDC) WAS ADVANCED INTO THE PULMONARY ARTERY. THE COIL HAD BEEN IN THE PATIENT FOR SOME TIME AND THE PHYSICIAN OPTED TO REMOVE THE COIL UPON DETERMINING IT WAS TOO LARGE. BLOOD FLOW WAS NOTED TO BE TURBULENT AND A GREAT AMOUNT OF FORCE WAS APPLIED TO PULL THE COIL INTO THE CATHETER. DURING WITHDRAWAL, WHILE IN THE HUB OF THE CATHETER, THE COIL BROKE AT AN UNKNOWN LOCATION. AS THE COIL WAS CONTAINED WITHIN THE CATHETER, THE DEVICES WERE REMOVED TOGETHER. THE PHYSICIAN NOTED THAT THE BREAK WAS LIKELY CAUSED BY TOO MUCH FORCE DURING WITHDRAWAL IN A SOFT CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT¿S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLOCK¿-35 DEVICE, EMBOLIZATION, VASCULAR KRD BOSTON SCIENTIFIC - CORK M001363590 14209309

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR .035" GLIDE CATHETER