BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPAQ - CERECYTE MICROCOIL

    MDR report key: 3162925 · Received June 11, 2013

    Report

    Report Number
    1226348-2013-20110
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 15, 2013
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K080437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE POSITIONING UNIT (DPU) PASSED ELECTRICAL TESTING. THE COIL DETACHED ON THE FIRST DETACHMENT ATTEMPT. THE DETACHMENT FIBER RECEIVED HEAT AND MELTED AS DESIGNED. LABORATORY TESTING COULD NOT DUPLICATE THE FIELD COMPLAINT AND NO INTERMITTENT ELECTRICAL FAILURE WAS FOUND. THEREFORE, THE ROOT CAUSE OF THE COILS INABILITY TO BE DETACHED INSIDE THE ANEURYSM CANNOT BE DETERMINED. IN ADDITION, WITHOUT THE RETURN OF THE COMPLETE DETACHMENT SYSTEM USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS CONTRIBUTED TO THE COMPLAINT EVENT. FURTHERMORE, IT WAS NOT STATED IN THE EVENT DESCRIPTION THAT A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED OR THAT THE DETACHMENT CONTROL BOX (DCB) AND THE CONNECTING CABLE WERE EXCHANGED DURING THE COILS NON DETACHMENT INSIDE THE ANEURYSM. FOR OPTIMUM PRODUCT PERFORMANCE AND TO PREVENT POTENTIAL COMPLICATIONS, ¿VERIFY THE FUNCTIONALITY OF THE MICRUS MICROCOIL DELIVERY SYSTEM BEFORE PROCEEDING WITH MICROCOIL PLACEMENT. THIS NEEDS TO BE DONE WITH THE MICROCOIL STILL IN THE HOOP. TO VERIFY PROPER DCB AND MICROCOIL FUNCTIONALITY A CONNECTING CABLE AND MICROCOIL MUST BE CONNECTED TO THE DCB UNIT. AFTER VERIFICATION OF THE DCB AND CONNECTING CABLE, TURN OFF POWER TO THE DCB AND DISCONNECT THE CONNECTING CABLE FROM THE MICROCOIL UNTIL THE MICROCOIL IS READY TO BE DETACHED. PLEASE REFER TO THE DETACHMENT CONTROL BOX INSTRUCTIONS FOR USE SECTION, LOCATED NEAR THE END OF THIS DOCUMENT, BEFORE PROCEEDING.¿ ¿¿VERIFY THAT THE MICROCOIL DELIVERY SYSTEM IS FULLY CONNECTED AND NO FAULTS ARE INDICTED ON THE DCB. IF A FAULT EXISTS, RESEAT ALL CONNECTIONS BETWEEN THE DPU, THE DCB, AND THE CONNECTING CABLE. IF A FAULT STILL PERSISTS, REPLACE THE CONNECTING CABLE. IF THIS DOES NOT CORRECT THE ERROR, REPLACE THE DCB. IF THE MICROCOIL DELIVERY SYSTEM STILL CONTINUES TO HAVE A FAULT, RETRIEVE THE MICROCOIL AS DESCRIBED IN THE FOLLOWING SECTION, RE SHEATHING THE MICROCOIL SYSTEM, AND REPLACE WITH A NEW MICROCOIL SYSTEM¿¿ IN ADDITION WITHOUT THE RETURN OF THE COMPLETE DETACHMENT SYSTEM USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS CONTRIBUTED TO THE COMPLAINT EVENT. CONCERNING COLLATERAL DAMAGE TO THE RETURNED MICROCOIL SYSTEM, THERE IS NO DIRECT CAUSAL RELATIONSHIP FROM THIS DAMAGE TO THIS SPECIFIC FIELD COMPLAINT OF THE COILS NON DETACHMENT INSIDE THE ANEURYSM. LOCATED OFF THE PROXIMAL END AT 15.0 AND 17.0 CENTIMETERS ARE TWO KINKS TO THE CORE WIRE. THE PROXIMAL SECTION OF THE RESHEATHING TOOL WAS SEVERED WITH THE DISTAL SECTION NOT RETURNED. THE RESHEATHING TOOLS FRACTURE IS DUCTILE IN NATURE REQUIRING EXTERNAL FORCE. NO MATERIAL DEFECTS WERE FOUND ON THE SEVERED PROXIMAL END. LOCATED 19.0 CENTIMETERS OFF THE DISTAL TIP OF THE GREEN INTRODUCER, THE CORE WIRE PROTRUDES OUTSIDE THE SHEATH FOR THE ENTIRE LENGTH BEFORE ENTERING THE RESHEATHING TOOL. LOCATED AT THE CORE WIRES PROTRUSION SITE AND ON THE REMAINDER OF THE SHEATH, NO MECHANICAL SHEATH DAMAGE WAS FOUND THAT RESULTED IN AN OPENED SKIVE. THE LAST TWO SECONDARY WINDINGS HAVE A MINOR DISTORTION BETWEEN THE PRIMARY WINDINGS THAT CAUSED THE HELICAL WINDING TO FLIP APPROXIMATELY A 90 DEGREE ANGLE TO THE FIRST TWO SECONDARY WINDINGS OFF THE BALL TIP. LOCATED ON THE TOP PROXIMAL END OF THE RESHEATHING TOOL IN THE OPEN CUTOUT SECTION, THE V NOTCH HAS BEEN FRACTURED AND THE SURROUNDED EDGES HAVE BEEN RAISED ABOVE THE SURFACE PLANE. THE LOCKING MECHANISM HAS BEEN DAMAGED WITH COMPRESSION AND STRETCHING OF THE SHEATH MATERIAL AWAY FROM THE SURFACE. THE PREVIOUSLY MENTIONED DAMAGE TO THE MICROCOIL SYSTEM 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 BECAME EMBEDDED INSIDE THE V NOTCH OF THE RESHEATHING TOOL AND THE EDGES EXTENDING OUTWARD OFF THE V NOTCHES APEX. THIS PRODUCED A BINDING ACTION BETWEEN THE DEVICE POSITIONING UNIT (DPU), THE SHEATH, AND THE COIL. THIS BINDING ACTION PRODUCED SIGNIFICANT RESISTANCE CAUSING THE RESHEATHING TOOL TO BE SEVERED INTO TWO PIECES, CORE WIRE TO KINK IN MULTIPLE SECTIONS AND TO FINALLY PROTRUDE OUTSIDE THE SHEATH, AND THE COILS DISTORTION OR LOSS OF CONTINUITY CONCERNING ITS HELICAL SECONDARY WINDING BETWEEN THE SECOND AND THIRD WINDINGS. 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¿¿ IN ADDITION, WITHOUT THE IDENTIFICATION OR THE RETURN OF THE UNKNOWN MICROCATHETER USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THIS COMPONENT CONTRIBUTED TO THE INCIDENTAL DAMAGE AS STATED IN THIS NARRATIVE. 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. LABORATORY TESTING COULD NOT DUPLICATE THE FIELD COMPLAINT AND NO INTERMITTENT ELECTRICAL FAILURE WAS FOUND. THEREFORE, THE ROOT CAUSE OF THE COILS INABILITY TO BE DETACHED INSIDE THE ANEURYSM CANNOT BE DETERMINED. IN ADDITION, WITHOUT THE RETURN OF THE COMPLETE DETACHMENT SYSTEM USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS CONTRIBUTED TO THE COMPLAINT EVENT. CONCERNING COLLATERAL DAMAGE TO THE RETURNED MICROCOIL SYSTEM, THERE IS NO DIRECT CAUSAL RELATIONSHIP FROM THIS DAMAGE TO THIS SPECIFIC FIELD COMPLAINT OF THE COILS NON DETACHMENT INSIDE THE ANEURYSM. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR USE, THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    THE COMPLAINT RECEIVED STATES THAT THE DELTAPAQ CERECYTE MICROCOIL 2 MM X 2 CM ((B)(4)) FAILED TO DETACH. THE PATIENT IS MALE, (B)(6). HE HAD TUMOR IN THE LEFT MIDDLE CEREBRAL ARTERY. THE COIL COULD NOT BE RELEASED DURING THE PROCEDURE. THE PHYSICIAN TRIED MANY TIMES BUT STILL FAILED. THEN HE WITHDREW IT AND CHANGED ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262540 DELTAPAQ - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA M10542

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR CABLE AND DCB