BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPAQ - CERECYTE MICROCOIL

    MDR report key: 3981935 · Received August 5, 2014

    Report

    Report Number
    1226348-2014-00170
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 10, 2014
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K080437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS VIEWED INTO THE RETURNED PACKAGING, IT WAS FOUND THAT THE COIL WAS RETURNED UNPROTECTED, UNSHEATHED, AND SEVERELY DAMAGED. THE PROXIMAL SECTION OF THE COIL HAS BEEN STRETCHED AND THE DISTAL SECTION OF THE COIL CONTAINING THE BALL TIP HAS BEEN BENT AWAY FROM THE REMAINING UNDAMAGED COILS. DUE TO THE POST-PROCEDURAL HANDLING AND PACKAGING OF THE EXPOSED COIL, IT CANNOT BE DETERMINED HOW MUCH COIL DAMAGE OCCURRED DURING THE PROCEDURE. LOCATED 27.0 CENTIMETERS OFF THE PROXIMAL END IS A SEVERE KINK TO THE CORE WIRE THAT APPEARS TO BE POST-PROCEDURAL IN NATURE. LOCATED OFF THE LOCKING MECHANISM THE SHEATH HAS BEEN SPILT LENGTHWISE FOR A DISTANCE OF 42.0 CENTIMETERS. THE CORE WIRE PROTRUDES OUTSIDE THE SHEATH AT THE DISTAL TIP OF THE SKIVE FOR THE ENTIRE LENGTH. NO MECHANICAL SHEATH DAMAGE RESULTING IN AN OPENED SKIVE WAS FOUND AT THE PROTRUSION SITE. THE SHEATH WAS SPILT LENGTHWISE FROM BEING EMBEDDED INSIDE THE RESHEATHING TOOLS V NOTCH CAUSING SEVERE DAMAGE. A PORTION OF THE SHEATH IS OBSERVED STILL PROTRUDING THROUGH THE FRACTURE. THE SHEATH WAS SEVERED AT THE LOCKING MECHANISM. THE MOST LIKELY CONTRIBUTING FACTOR TO THE SHEATH ¿STRETCHING AND SPLITTING OPEN¿ MAY HAVE OCCURRED WHEN THE MICROCOIL SYSTEM WAS FIRST UNLOCKED FOR USE AND THE SHEATH WAS RETRACTED STRAIGHT BACK INSTEAD OF UP AT A FORTY-FIVE DEGREE ANGLE AND THEN BACK.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 CORE WIRE AND CAUSED IT TO PROTRUDE OUTSIDE THE SHEATH, PUSHED THE COIL¿S SOCKET RING DOWN INSIDE THE SHEATH, AND MAY HAVE CAUSED A PORTION OF THE COIL DAMAGE FOUND. 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).¿ IN ADDITION, WITHOUT THE IDENTIFICATION OR THE RETURN OF THE UNKNOWN MICROCATHETER AND THE ROTATING HEMOSTATIC VALVE (RHV) USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS HAD ANY ADDITIONAL CONTRIBUTIONS 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.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: ALTHOUGH A DEFINITIVE CONCLUSION CANNOT BE MADE, BASED ON THE ANALYSIS, IT APPEARS THAT PROCEDURAL FACTORS RELATED TO THE UNSHEATHING PROCESS AS ADDRESSED IN THE IFU IS A POSSIBLE FACTOR CONTRIBUTING TO THE THE SHEATH DAMAGE. DUE TO POST PROCEDURE HANDLING AND PACKAGING OF THE RETURNED COIL, IT CANNOT BE DETERMINED HOW MUCH OF THE COIL DAMAGE WAS RELATED TO THE PROCEDURE. ADDITIONALLY, REVIEW OF THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AFTER UNZIPPING AND WHILE DELIVERING THE POSITIONING WIRE OF THE DELTAPAQ CERECYTE (CDF10020830/C20527), THE INTRODUCER SHEATH WAS STRETCHED AND SPLIT OPEN. IT WAS STATED IT HAPPENED AROUND THE MIDDLE OF THE INTRODUCER SHEATH. THE STRETCH WAS REPORTEDLY NOT LARGE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY AS A RESULT OF THE ISSUE. THE CLEAR TAB OF THE INTRODUCER SHEATH WAS PULLED OUT AND AWAY FROM THE RE-SHEATHING TOOL AT A 45-DEGREE ANGLE TO UNLOCK THE COIL PER THE IFU. DURING FAILURE ANALYSIS ON (B)(4) 2014 IT WAS FOUND THAT THE COIL WAS RETURNED UNPROTECTED, UNSHEATHED AND SEVERELY DAMAGED. THE PROXIMAL SECTION OF THE COIL HAS BEEN STRETCHED AND THE DISTAL SECTION OF THE COIL CONTAINING THE BALL TIP HAS BEEN BENT AWAY FROM THE REMAINING UNDAMAGED COILS. NO PATIENT OR VESSEL CODE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457574 DELTAPAQ - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA C20527

    Patients

    Seq Age Sex Outcome Treatment
    1