BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESIDIO 18 - CERECYTE MICROCOIL

    MDR report key: 3920888 · Received July 8, 2014

    Report

    Report Number
    1226348-2014-00139
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K002056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR ANALYSIS. AS VIEWED INTO THE RETURNED PACKAGING IT WAS OBSERVED THAT THE COIL WAS DETACHED FROM THE DEVICE POSITIONING UNIT (DPU) AND STRETCHED AT THE PROXIMAL SECTION. THE COIL¿S SOCKET RING HAS BEEN PUSHED DOWN INSIDE THE OUTER SHEATH AND THAT THE PROXIMAL END OF THE COIL IS STILL ATTACHED TO THE DPU VIA THE DETACHMENT FIBER. THE REMAINDER OF THE COIL WAS UNRAVELED OUT OF THE SOLDERED SECTION AND SEVERED. NO MATERIAL DEFECTS WERE FOUND. THE DISTAL SECTION OF THE COIL WAS NOT STRETCHED, BUT WAS STILL FOUND DAMAGED. THE MOST LIKELY CONTRIBUTING FACTOR TO THE COILS UNINTENDED DETACHMENT OCCURRED WHEN THE END USER WAS RETRACTING THE COIL OUT OF THE ANEURYSM TO EXCHANGE FOR ANOTHER COIL. THE COIL MOST LIKELY BECAME TEMPORARILY ANCHORED BY THE COILS ALREADY DWELLING INSIDE THE ANEURYSM, ON ITSELF, OR ON THE DISTAL TIP OF THE MICROCATHETER. WHEN THE ANCHORED COIL WAS RETRACTED, IT MOST LIKELY UNRAVELED OUT OF THE SOLDERED SECTION AND SEPARATED FROM THE REMAINDER OF THE COIL STILL ATTACHED TO THE DPU. IT WAS NOT STATED IF A ONE TO ONE MOVEMENT OF THE COIL TO THE DELIVERY WIRE WAS OBSERVED DURING REMOVAL. FOR OPTIMUM PRODUCT PERFORMANCE AND TO PREVENT POTENTIAL COMPLICATIONS, THE INSTRUCTIONS FOR USE IFU) RECOMMENDS, ¿CAUTION: IF REPOSITIONING OF THE MICROCOIL IS NECESSARY, CAREFULLY OBSERVE THE MOTION OF THE MICROCOIL IN RESPECT TO THE DPU WIRE WHILE RETRACTING THE MICROCOIL UNDER FLUOROSCOPY. IF THE MICROCOIL MOVEMENT IS NOT ONE-TO-ONE WITH THE DPU WIRE, OR IF REPOSITIONING IS DIFFICULT, THE MICROCOIL MAY HAVE BECOME STRETCHED AND COULD POSSIBLY BREAK. GENTLY REMOVE AND DISCARD THE MICROCOIL SYSTEM. CAUTION: IF THE MICROCOIL IS POSITIONED AT A RELATIVE SHARP ANGLE TO THE MICROCATHETER, A MICROCOIL MAY STRETCH OR BREAK AS IT IS BEING WITHDRAWN. BY REPOSITIONING THE DISTAL TIP OF THE CATHETER AT OR SLIGHTLY INSIDE THE OSTIUM OF THE ANEURYSM, THE MICROCOIL MAY BE MORE EASILY FUNNELED BACK INTO THE MICROCATHETER.¿ IN ADDITION, WITHOUT THE RETURN OF THE HEADWAY MICROCATHETER USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THIS 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. ALTHOUGH A DEFINITIVE CONCLUSION CANNOT BE MADE, BASED ON THE ANALYSIS, IT APPEARS THAT PROCEDURAL FACTORS RELATED TO REPOSITIONING THE COIL AND ENTANGLEMENT WITH OTHER COILS IN THE PROCEDURE MAY HAVE CAUSED 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.

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION, THE EVENT COULD NOT BE CONFIRMED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; HOWEVER 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. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING EMBOLIZATION OF AN INTERNAL CAROTID ARTERY ANEURYSM, WHEN THE PHYSICIAN TRIED TO RETRACT THE PRESIDIO (PC418103430/C21286) FROM THE ANEURYSM TO CHANGE TO ANOTHER COIL BECAUSE OF IMPROPER SIZE, HE FOUND IT WAS DETACHED ALREADY. THE ANEURYSM WAS APPROXIMATELY 4 MM IN DIAMETER AND WAS A SIDEWALL ANEURYSM. A HEADWAY MICROCATHETER (DETAILS UNKNOWN) WAS USED IN THE PROCEDURE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER AT ALL TIMES. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND MICROCATHETER WHEN ACCESSING THE TARGET SITE. THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MICROCATHETER. PRIOR TO THIS COIL, OTHER COILS (DETAILS UNKNOWN) WENT THROUGH THE MICROCATHETER WITHOUT RESISTANCE. THERE WERE NO KINKS IN THE MICROCATHETER. THE MICROCATHETER WAS NOT REPOSITIONED OVER THE COIL WHILE THE COIL WAS DEPLOYED OR PARTIALLY DEPLOYED OUT OF THE DISTAL END OF THE MICROCATHETER. A ONE TO ONE RELATIONSHIP BETWEEN THE COIL AND DELIVERY TUBE WAS NOT VERIFIED WITH FLUORO PRIOR TO REPOSITIONING. IT IS UNKNOWN WHETHER COIL ENTANGLEMENT WITH PREVIOUSLY PLACED COILS SUSPECTED TO CONTRIBUTE TO THE EVENT. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THE DETACHED COIL WAS STUCK IN THE MICROCATHETER AND THE ENTIRE COIL WAS REMOVED FROM THE PATIENT BY PULLING OUT THE MICROCATHETER AND COIL TOGETHER. THERE WAS NO FLOW RESTRICTION/REDUCTION AS A RESULT OF THE ISSUE. THERE WAS NO ADVERSE OUTCOME TO THE PATIENT AS A RESULT OF THE EVENT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE TIMING OF THE PROCEDURE. THE COIL DID NOT STRETCH PRIOR TO DETACHMENT AND THE COIL DID NOT BREAK INTO PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398297 PRESIDIO 18 - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA C21286

    Patients

    Seq Age Sex Outcome Treatment
    1