BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPAQ - CERECYTE MICROCOIL

    MDR report key: 3910913 · Received July 2, 2014

    Report

    Report Number
    1226348-2014-00135
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 8, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K080437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COIL WAS RETURNED UNDAMAGED AND WAS NOT STRETCHED AS REPORTED IN THE EVENT DESCRIPTION. LOCATED OFF THE PROXIMAL END AT 19.0, 20.0, 68.0, & 69.0 (ALL IN CENTIMETERS) ARE SEVERE KINKS ON THE CORE WIRE. LOCATED 6.7 CENTIMETERS OFF THE DISTAL TIP OF THE GREEN INTRODUCER IS A KINK. THIS KINK CLOSELY ALIGNS UP WITH THE RUBBER ADJUSTABLE GASKET INSIDE THE LAB¿S IN-HOUSE ROTATING HEMOSTATIC VALVE (RHV). LOCATED 32.0 CENTIMETERS OFF THE DISTAL TIP OF THE GREEN INTRODUCER, THE CORE WIRE PROTRUDES OUTSIDE THE SHEATH. THERE IS NO MECHANICAL SHEATH DAMAGE RESULTING IN AN OPENED SKIVE AT THE PROTRUSION SITE. LOCATED ON THE TOP PROXIMAL END OF THE RESHEATHING TOOL IN THE OPEN CUTOUT SECTION, THE V NOTCH HAS BEEN SEVERELY DAMAGED WITH THE DAMAGED EDGES RAISED ABOVE THE SURFACE PLANE. THE LOCKING MECHANISM HAS TOOLING INDENTATIONS BY THE RESHEATHING TOOL WITH ADDITIONAL COMPRESSION AND STRETCHING DAMAGE FOUND. USING AN IN-HOUSE ECHELON 10 MICROCATHETER, THE RETURNED COIL WAS INTRODUCED MULTIPLE TIMES WITH NO RESISTANCE ENCOUNTERED. THE COIL WAS THEN ADVANCED THROUGH AND OUT THE DISTAL TIP OF THE MICROCATHETER MULTIPLE TIMES WITH NO PROBLEMS ENCOUNTERED. THE COIL MOVED FREELY AT ALL TIMES. THERE ARE TWO POSSIBLE CONTRIBUTING FACTORS TO THE FRICTION FELT DURING THE COILS ADVANCEMENT INSIDE THE MICROCATHETER. THESE CONTRIBUTING FACTORS MAY HAVE WORKED IN TANDEM OR SEPARATELY WITH EACH CAPABLE OF PRODUCING SIMILAR RESULTS. THE PRIMARY CONTRIBUTING FACTOR TO THE FRICTION FELT DURING COIL ADVANCEMENT MAY HAVE OCCURRED WHEN THE MICROCOIL SYSTEM WAS FIRST UNLOCKED FOR USE AND THE SHEATH WAS RETRACTED STRAIGHT BACK INSTEAD OF UP AT A FORTY-FIVE DEGREE ANGLE AND THEN BACK. WHEN THE SHEATH WAS PULLED STRAIGHT BACK, THE LOCKING MECHANISM CAUGHT THE INSIDE OF THE V NOTCH OF THE RESHEATHING TOOL AND BECAME EMBEDDED. IN ADDITION, THE LOCKING MECHANISM MAY NOT HAVE BEEN FULLY DISENGAGED OFF THE CORE WIRE. THE SHEATH ALSO CAUGHT THE V NOTCHES EXTENDED EDGES. THIS PRODUCED A BINDING ACTION BETWEEN THE DEVICE POSITIONING UNIT (DPU), THE SHEATH, AND THE COIL. THIS BINDING ACTION PRODUCED SIGNIFICANT RESISTANCE WHICH BENT THE DELIVERY WIRE IN MULTIPLE LOCATIONS AND CAUSED THE CORE WIRE TO PROTRUDE OUTSIDE THE SHEATH. IN THIS CONDITION THE COIL CANNOT BE ADVANCED OR RESHEATHED. FOR OPTIMUM PRODUCT PERFORMANCE AND TO PREVENT POTENTIAL COMPLICATIONS, THE INSTRUCTIONS FOR USE (IFU) RECOMMENDS, ¿HOLD THE INTRODUCER SHEATH (LOOSELY-LOOPED) IN THE LEFT HAND. KEEPING THE INTRODUCER TIP NEAR THE RE-SHEATHING TOOL, GRASP THE DISTAL END OF THE RE-SHEATHING TOOL BETWEEN YOUR LEFT THUMB AND FOREFINGER. GRASP THE CLEAR TAB NEAR THE END OF THE INTRODUCER SHEATH BODY WITH THE THUMB AND FOREFINGER OF YOUR OTHER HAND. GENTLY PULL THE CLEAR TAB OF THE INTRODUCER SHEATH OUT AND AWAY FROM THE RE SHEATHING TOOL AT A 45-DEGREE ANGLE TO UNLOCK THE MICROCOIL. CONTINUE TO PULL THE TAB UNTIL AN ADDITIONAL 0.5 TO 1.0 INCHES (1.3 TO 2.5 CM) OF THE TRANSLUCENT MATERIAL IS EXPOSED. GENTLY FOLD THE TRANSLUCENT TAB TOWARDS THE DISTAL END, AND FIRMLY GRASP THE DISTAL END OF THE RE SHEATHING TOOL AND THE TRANSLUCENT TAB BETWEEN YOUR THUMB AND FOREFINGER, AS SHOWN IN FIGURE 3¿¿ CAUTION: IF UNUSUAL FRICTION IS NOTICED DURING ADVANCEMENT OR RETRACTION OF THE MICROCOIL SYSTEM, VERIFY THE LOCKING MECHANISM, OR CLEAR TAB IS UNLOCKED AND PULLED OUT FROM THE RESHEATHING TOOL APPROXIMATELY 1IN. (2-3CM).¿ THE SECONDARY CONTRIBUTING FACTOR MAY HAVE BEEN DUE TO INTERFERENCE. WHILE THE EXACT SOURCE OF THIS INTERFERENCE; WHETHER OF A FIXED OR DETACHED NATURE CANNOT BE DETERMINED, ONE SOURCE OF INTERFERENCE FOUND FROM THE EVIDENCE SUGGESTS THAT IT MAY HAVE BEEN THAT THE GREEN INTRODUCER WHICH MAY HAVE BEEN BENT AND COMPRESSED DUE TO AN OVER-TIGHTENING OF THE ADJUSTABLE RUBBER GASKET INSIDE THE RHV. THIS WOULD HAVE CAUSED COIL FRICTION, MULTIPLE LOCATIONS OF SEVERE KINKS TO THE CORE WIRE, AND THE PROTRUSION OF THE CORE WIRE OUTSIDE THE SHEATH. IN THIS CONDITION SEVERE RESISTANCE WOULD BE ENCOUNTERED WHEN ATTEMPTING TO ADVANCE THE COIL. IF THIS OCCURRED, FOR OPTIMUM PRODUCT PERFORMANCE AND TO PREVENT POTENTIAL COMPLICATIONS, THE INSTRUCTIONS FOR USE (IFU) RECOMMENDS, ¿CAUTION: DO NOT FASTEN THE RHV VALVE TOO TIGHTLY AROUND THE INTRODUCER SHEATH SINCE EXCESSIVE PRESSURE MAY CAUSE DAMAGE TO THE INTRODUCER SHEATH AND/OR THE MICROCOIL AS IT IS ADVANCED INTO THE INFUSION MICROCATHETER. ADDITIONALLY, IF THE INTRODUCER TIP AND MICROCATHETER HUB ARE MISALIGNED, DAMAGE MAY OCCUR TO THE MICROCOIL AS IT PASSES THROUGH THIS TRANSITION. IN ADDITION, WITHOUT THE RETURN OF THE ECHELON 10 MICROCATHETER AND THE RHV USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS CONTRIBUTED TO THE COMPLAINT EVENT. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. BASED ON THE INFORMATION AND ANALYSIS, THE EVENT WAS NOT CONFIRMED. PROCEDURAL FACTORS OUTLINED IN THE IFU MAY HAVE ALSO CONTRIBUTED TO THE EVENT. THE RETURNED PRODUCT PASSED TESTING AND A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE MICROCATHETER AND RHV, WHICH WERE NOT RETURNED MAY HAVE CONTRIBUTED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE PRODUCT WILL BE RETURNED FOR ANALYSIS, HOWEVER IT HAS NOT BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE SURGEON FELT FRICTION AT THE DISTAL END OF THE ECHELON 10 MICROCATHETER(DETAILS UNKNOWN) WHEN HE ADVANCED THE FOURTH COIL, A DELTAPAQ (CDF10020830/G14278) FOR A BASILAR ARTERY ANEURYSM. THE SURGEON WITHDREW THE DELIVERY WIRE AND TRIED MANY TIMES TO ADVANCE BUT STILL FAILED. THE COIL STRETCHED PRIOR TO COMPLETELY REMOVING FROM THE PATIENT. THE MICROCATHETER WAS NOT REMOVED WITH THE COIL. THE SURGEON CHANGED TO ANOTHER SIMILAR COIL(DETAILS UNKNOWN) TO COMPLETE. NO ADVERSE EVENT OCCURRED. THE COIL AND MICROCATHETER DID NOT KINK OR BEND AT ANY TIME PRIOR TO THE RESISTANCE/FRICTION. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER AT ALL TIMES. OTHER UNKNOWN PRODUCTS WERE USED SUCCESSFULLY WITH THE MICROCATHETER PRIOR TO AND AFTER THE ENCOUNTERED RESISTANCE. THERE WAS NO SIGNIFICANT DELAY IN THE TIMING OF THE PROCEDURE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386451 DELTAPAQ - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA G14278

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR