BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPLUSH - CERECYTE MICROCOIL

    MDR report key: 3110791 · Received May 14, 2013

    Report

    Report Number
    1226348-2013-20091
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 19, 2013
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K083646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COIL WAS RETURNED WITH BUCKLING AND COMPRESSION DAMAGE TO THE PROXIMAL END OF THE COIL. THE COIL'S SOCKET RING HAS BEEN PUSHED DOWN INSIDE THE OUTER SHEATH. THE TIP COIL WAS FOUND PROTRUDING OUTSIDE THE SHEATH. NO MECHANICAL SHEATH DAMAGE RESULTING IN AN OPENED SKIVE WAS FOUND AT THE PROTRUSION SITE. LOCATED ON THE TOP PROXIMAL END OF THE RESHEATHING TOOL IN THE OPEN CUTOUT SECTION, THE V NOTCH AND THE EDGES EXTENDED FROM IT HAVE BEEN DAMAGED. THE DAMAGED EDGE HAS BEEN RAISED ABOVE THE SURFACE PLANE. THE LOCKING MECHANISM HAS BEEN DAMAGED WITH COMPRESSION AND THE STRETCHING OF THE SHEATH MATERIAL AWAY FROM THE SURFACE. THE MOST LIKELY CONTRIBUTING FACTOR TO THE SEVERE RESISTANCE AND THE INABILITY OF THE COIL TO BE ADVANCED OCCURRED WHEN THE MICROCOIL SYSTEM WAS FIRST UNLOCKED FOR USE AND THE SHEATH WAS RETRACTED STRAIGHT BACK INSTEAD OF UP AT A FORTY-FIVE DEGREE ANGLE AND THEN BACK.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 AND ALSO CAUGHT THE OUTER EDGE OF THE V NOTCH OF THE RESHEATHING TOOL. THIS PRODUCED A BINDING ACTION BETWEEN THE DEVICE POSITIONING UNIT (DPU), THE SHEATH, AND THE COIL. THIS BINDING ACTION PRODUCED SIGNIFICANT RESISTANCE CAUSING THE DAMAGE TO THE PROXIMAL END OF THE COIL AND PREVENTING THE COIL FROM BEING ADVANCED IN THE MICROCATHETER. 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. IN ADDITION, WITHOUT THE IDENTIFICATION OR THE RETURN OF THE SL-10 MICROCATHETER AND THE ROTATING HEMOSTATIC VALVE (RHV) USED IN THE PROCEDURE, IT CANNOT BE DETERMINED. 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 CIRCUMSTANCES OF HOW AND WHERE THE COILS WERE DAMAGED CANNOT BE DETERMINED. IT WAS STATED THAT BEFORE USE THE DEVICE WAS NOT DAMAGED. FOR OPTIMUM PRODUCT PERFORMANCE AND TO PREVENT POTENTIAL COMPLICATIONS, THE INSTRUCTIONS FOR USE (IFU) PROVIDES GUIDANCE ON THE PROPER WAY TO REMOVE THE DEVICE IN ORDER AVOID DAMAGES ON THE DEVICE. 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 COMPLAINTS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    DURING THE COIL EMBOLIZATION PROCEDURE OF THE RIGHT EXTERNAL CAROTID ARTERY, WHEN THE INTRODUCER SHEATH OF THE DELTAPLUSH MICROCOIL (CPL100206-30/C13817) WAS INSERTED THROUGH AN UNSPECIFIED Y-CONNECTOR AND THE INTRODUCER TIP WAS SEATED INTO THE HUB OF THE UNSPECIFIED EXCELSIOR SL10 45 DEGREES MICROCATHETER (STRYKER), SEVERE RESISTANCE OCCURRED AT THE HUB OF THE MICROCATHETER AND COULD NOT ADVANCE IT ANY FURTHER. HOWEVER, THE ANALYSIS FOUND THAT THE COUL WAS SEVERELY DAMAGED. THEN, THE DELTAPLUSH WAS SAFELY REMOVED FROM THE MICROCATHETER AND WAS REPLACED FOR A NEW SIMILAR PRODUCT WITH DIFFERENT LOT (CPL100206-30/ G14102). HOWEVER, AFTER THAT, SAME THING OCCURRED USING THE REPLACED DELTAPLUSH. THE PHYSICIAN PUT ADDITIONAL FORCE TO PUSH THE COIL, AROUND MIDDLE SECTION OF THE INTRODUCER SHEATH OF THE REPLACED DELTAPLUSH SPLIT OPEN AND THE COIL EXPOSED FROM THE DAMAGED AREA. THEREFORE, THE REPLACED DELTAPLUSH WAS SAFELY REMOVED AGAIN FROM THE MICROCATHETER AND THE PROCEDURE WAS ALSO CONTINUED USING A NEW UNSPECIFIED ORBIT COIL (CATALOGUE AND LOT UNKNOWN). AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. DURING THAT TIME, THE PROCEDURE WAS MADE ALL WAY THROUGH THE SAME MICROCATHETER. THE COMPLAINT PRODUCTS WERE NEW AND WERE STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. PRIOR TO USE, NO DEFECT (KINK, BENDS ETC) WAS NOTED ON THE PRODUCTS BY VISUAL INSPECTION. THERE WAS NO STRETCHING OR UNINTENDED DETACHMENT OBSERVED IN THE MICROCATHETER. IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. THE VESSEL WAS MILDLY CALCIFIED AND MILDLY TORTUOUS. THE COMPLAINT PRODUCTS ARE GOING TO BE RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212044 DELTAPLUSH - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA C13817

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR SL10 45 DEGREES MICROCATHETER