BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESIDIO 10 - CERECYTE MICROCOIL

    MDR report key: 4201042 · Received October 27, 2014

    Report

    Report Number
    2954740-2014-50016
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    May 15, 2011
    Report Date
    October 24, 2014
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K002056
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: ECHELON 10 MICROCATHETER (DETAILS UNKNOWN), ANOTHER MICROCATHETER (DETAILS UNKNOWN), ANOTHER PRESIDIO COIL (DETAILS UNKNOWN). THE ECHELON 10 MICROCATHETER WAS NOT RETURNED. THE MICROCOIL SYSTEM WAS RETURNED CLEANED. LOCATED ON THE TOP PROXIMAL END OF THE RESHEATHING TOOL, THE V NOTCH HAS BEEN SEVERELY DAMAGED. THE DAMAGED MATERIAL AT THE DISTAL END OF THE V NOTCH HAS BEEN RAISED ABOVE THE SURFACE PLANE. LOCATED AT THE LOCKING MECHANISM, MATERIAL HAS BEEN STRETCHED AND TORN AWAY FROM THE SURFACE. THE COIL WAS RETURNED UNDAMAGED. THE COIL'S SOCKET RING IS OFF THE SIDE AND UNDER THE ANGLE RING. NOTE THAT THE ANGLE RING EXHIBITS COMPRESSION. THIS LOCATION OF THE ANGLE RING DID NOT AFFECT THE COILS ADVANCEMENT INSIDE THE SHEATH OR MICROCATHETER. USING AN IN-HOUSE ECHELON 10 MICROCATHETER, THE COIL WAS INTRODUCED MULTIPLE TIMES WITH NO PROBLEMS ENCOUNTERED. THE COIL WAS THEN ADVANCED THROUGH AND OUT THE DISTAL TIP OF THE MICROCATHETER MULTIPLE TIMES WITH NO RESISTANCE FOUND. THE COIL WAS RETURNED UNDAMAGED. TWO CONTRIBUTING FACTORS WERE FOUND THAT MAY HAVE PRODUCED RESISTANCE INSIDE THE MICROCATHETER. THE FIRST CONTRIBUTING FACTOR WAS WHEN THE LOCKING MECHANISM CAUGHT THE V NOTCH OF THE RESHEATHING TOOL. THIS WILL CAUSE THE DEVICE POSITIONING UNIT (DPU) AND THE SHEATH TO BIND TOGETHER. IN THIS CONDITION SIGNIFICANT RESISTANCE WILL OCCUR DURING COIL ADVANCEMENT INSIDE THE MICROCATHETER. FOR OPTIMUM PRODUCT PERFORMANCE AND TO PREVENT POTENTIAL COMPLICATIONS, THE INSTRUCTIONS FOR USE (IFU) RECOMMENDS," 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 IN (1.3 TO 2.5 EM) 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.." THE SECOND CONTRIBUTING FACTOR MAY HAVE BEEN INTERFERENCE INSIDE THE MICROCATHETER. HOWEVER, WITHOUT THE RETURN OF THE ECHELON 10 MICROCATHETER USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THIS COMPONENT CONTRIBUTED TO THE COMPLAINT EVENT. ALTHOUGH A DEFINITIVE CONCLUSION CANNOT BE MADE, BASED ON THE ANALYSIS, IT APPEARS THAT PROCEDURAL FACTORS AND/OR INTERFERENCE IN THE MICROCATHETER WERE THE CONTRIBUTING FACTORS TO THE EVENT. 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. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AS THE RESULT OF A RECENT FDA AUDIT AND WITH ACCORDANCE TO THE REQUIREMENTS OF CODE OF FEDERAL REGULATIONS - 21 CFR PART 803, MEDICAL DEVICE REPORTING.

    Description of Event or Problem · 1

    DURING A NEUROVASCULAR TREATMENT OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM WHILE ATTEMPTING TO LOAD A PRESIDIO COIL (PC410041230/G12776) INTO AN ECHELON 10 MICROCATHETER (DETAILS UNKNOWN), THE PHYSICIAN FELT RESISTANCE WHEN PUSHING THE COIL THROUGH THE MICROCATHETER , SO HE REMOVED THE COIL & THE MICROCATHETER & REPLACED WITH A NEW MICROCATHETER (DETAILS UNKNOWN) & NEW PRESIDIO COIL (DETAILS UNKNOWN) WHICH WORKED FINE. THERE WAS NO ADVERSE PATIENT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682294 PRESIDIO 10 - CERECYTE MICROCOIL CNV DCS COILS HCG CODMAN AND SHURTLEFF, INC PC410041230 G12776

    Patients

    Seq Age Sex Outcome Treatment
    1