BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIX STRETCH RESISTANT (SR) COILS

    MDR report key: 1954518 · Received January 10, 2011

    Report

    Report Number
    2939204-2010-01176
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 18, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K050700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE MAIN COIL WAS NOT ATTACHED TO THE DISTAL END OF THE PUSHERWIRE. THE MAIN COIL WAS IN THE MICROCATHETER. A 0.0158 MANDREL WAS ADVANCED THROUGH THE MICROCATHETER TO PUSH THE COIL AND A SUBSTANTIAL AMOUNT OF BLOOD EXITED THE DISTAL END OF THE MICROCATHETER. THE MANDREL MET SEVERE RESISTANCE IN THE MID SECTION OF THE MICROCATHETER. THE CATHETER WAS CUT AND THE COIL WAS FOUND TO BE JAMMED IN THE CATHETER. BLOOD MATTER WAS EVIDENT ON THE COIL. FURTHER MICROSCOPIC EXAMINATION SHOWED THAT THE POLYETHYLINE (PET) JUNCTION WAS STILL PRESENT ON THE PROXIMAL TIP OF THE COIL INDICATING THAT THE COIL DETACHED FROM THE PUSHERWIRE AT THE MAIN JUNCTION AND NOT THE DETACHMENT ZONE. THE PROXIMAL END OF THE COIL WAS STRETCHED. THE INNER COIL WAS STILL ATTACHED TO THE DISTAL END OF THE DELIVERY WIRE INDICATING THAT THE COIL WAS NOT DETACHED BY ELECTROLYSIS AS THE DETACHMENT ZONE WAS STILL INTACT. THE PET WAS MISSING FROM THE DISTAL TIP OF THE INNER COIL INDICATING THAT FORCE WAS EXERTED ON THE DEVICE AND THE COIL SEPARATED FROM THE DELIVERY WIRE AT THE PET JUNCTION. THE PHYSICIAN STATED THAT CONTINUOUS FLUSH WAS MAINTAINED; HOWEVER, THE PRESENCE OF A SUBSTANTIAL AMOUNT OF BLOOD IN THE MICROCATHETER AND ON THE MAIN COIL INDICATES THAT FLUSH WAS NOT SUFFICIENT TO PREVENT THROMBUS BUILD UP. THE DIRECTIONS FOR USE (DFU) STATE: "TO ACHIEVE OPTIMAL PERFORMANCE OF THE MATRIX2 DETACHABLE COIL SYSTEM AND TO REDUCE THE RISK OF THROMBOEMBOLIC COMPLICATIONS, IT IS CRITICAL THAT A CONTINUOUS INFUSION OF AN APPROPRIATE FLUSH SOLUTION BE MAINTAINED." BASED ON THE INVESTIGATION RESULTS AND INFORMATION AVAILABLE IT IS LIKELY THAT INSUFFICIENT FLUSH WAS THE CAUSE OF THE DIFFICULTIES IN POSITIONING THE COIL AND LATER IN WITHDRAWING THE COIL FROM THE MICROCATHETER. THE ANATOMY WAS ALSO REPORTED TO BE QUITE TORTUOUS WHICH MAY HAVE CONTRIBUTED TO THE DIFFICULTIES. BLOOD WITHIN THE CATHETER SHAFT WOULD HAVE CAUSED RESISTANCE WHEN AN ATTEMPT WAS MADE TO RETRACT THE COIL, WHICH IN TURN WOULD LEAD TO MORE FORCE TO BE REQUIRED TO WITHDRAW THE DEVICE WHICH CAUSED THE DEVICE TO STRETCH AND EVENTUALLY BREAK AT THE PET MAIN JUNCTION. THEREFORE, IT WAS CONCLUDED THAT USE/USER ERROR WAS THE MOST PROBABLE CAUSE FOR THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY. IT WAS REPORTED THAT THE ANATOMY WAS "QUITE TORTUOUS" AND AS THE PHYSICIAN WAS WITHDRAWING THE COIL RESISTANCE WAS ENCOUNTERED IN THE MID PART OF THE MICROCATHETER. CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    THE PHYSICIAN ENCOUNTERED DIFFICULTIES IN POSITIONING THE COIL INSIDE THE TARGET INTERNAL CAROTID ARTERY (ICA) ANEURYSM. THE PHYSICIAN ATTEMPTED TO REPOSITION THE COIL SEVERAL TIMES BUT WAS UNSUCCESSFUL. UPON WITHDRAWAL, PART OF THE COIL BROKE AND WAS LEFT INSIDE THE MICROCATHETER. THE MICROCATHETER AND THE BROKEN PART OF THE COIL WERE WITHDRAWN AS ONE UNIT. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME MICROCATHETER AND TWO OTHER COILS. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT WHO WAS REPORTEDLY IN A STABLE CONDITION.

    Description of Event or Problem · 1

    THE PHYSICIAN ENCOUNTERED DIFFICULTIES IN POSITIONING THE COIL INSIDE THE TARGET INTERNAL CAROTID ARTERY (ICA) ANEURYSM. THE PHYSICIAN ATTEMPTED TO REPOSITION THE COIL SEVERAL TIMES BUT WAS UNSUCCESSFUL. UPON WITHDRAWAL, PART OF THE COIL BROKE AND WAS LEFT INSIDE THE MICROCATHETER. THE MICROCATHETER AND THE BROKEN PART OF THE COIL WERE WITHDRAWN AS ONE UNIT. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME MICROCATHETER AND TWO OTHER COILS. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT WHO WAS REPORTEDLY IN A STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX STRETCH RESISTANT (SR) COILS DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK M003490304SR0 13501853

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR EXCELSIOR SL-10 MICROCATHETER (BOSTON SCIENTIFIC)