BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESIDIO 10 - CERECYTE MICROCOIL

    MDR report key: 3030940 · Received April 2, 2013

    Report

    Report Number
    1226348-2013-20063
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 21, 2013
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K002056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: - NEW COIL (DETAILS UNKNOWN). - MICROCATHETER (DETAILS UNKNOWN).

    Additional Manufacturer Narrative · 1

    THE PRESIDIO 10 CERECYTE MICROCOIL 5 MM X 17 CM (B)(4) WAS STRETCHED DURING TREATMENT OF A 5.35X8.34MM POSTERIOR COMMUNICATING ARTERY ANEURYSM. THE COIL DID NOT COMPLETELY FILL THE ANEURYSM WHEN PLACING IN THE ANEURYSM, WHEN THE COIL WAS WITHDRAWN TO RE-FILL, IT WAS FOUND TO BE STRETCHED. THE COIL WAS WITHDRAWN AND CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. THE COIL REMAINED ATTACHED TO THE DELIVERY SYSTEM WHEN IT WAS WITHDRAWN. THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT, REPOSITIONING, WITHDRAWAL OF THE COIL THROUGH THE MICROCATHETER. COIL ENTANGLEMENT WITH PREVIOUSLY PLACED COILS WAS NOT SUSPECTED TO CONTRIBUTE TO THE EVENT. THE COIL WAS RETURNED WITH EXTENSIVE BUCKLING, COMPRESSION, AND STRETCHING DAMAGE. THE COIL'S SOCKET RING WAS FOUND PUSHED DOWN INSIDE THE OUTER SHEATH. THE MOST LIKELY CONTRIBUTING FACTOR TO THE COIL STRETCHING DURING REPOSITIONING INSIDE THE ANEURYSM WAS DUE TO THE COIL BECOMING TEMPORARILY ANCHORED. THIS MAY HAVE BEEN RELATED TO COILS ALREADY DWELLING INSIDE THE ANEURYSM, ON ITS SELF, OR FROM CATCHING THE EDGE OF THE DISTAL TIP OF THE MICROCATHETER DURING RETRACTION. THE COMPRESSION AND BUCKLING DAMAGE FOUND TO THE COIL WAS MOST LIKELY DUE TO DISTAL INTERFERENCE WHICH MAY HAVE BEEN FROM THE COILS ALREADY DWELLING INSIDE THE ANEURYSM OR FROM ANOTHER FORM OF DISTAL INTERFERENCE. THE SOURCE OF THIS INTERFERENCE; WHETHER OF A FIXED OR DETACHED NATURE CANNOT BE DETERMINED. FOR OPTIMUM PRODUCT PERFORMANCE AND TO PREVENT POTENTIAL COMPLICATIONS, THE INSTRUCTIONS FOR USE (IFU) OUTLINES '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 IDENTIFICATION OR THE RETURN OF THE UNKNOWN MICROCATHETER USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THIS COMPONENT 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. WITH REVIEW OF THE AVAILABLE REPORTED INFORMATION AND THE ANALYSIS OF THE RETURNED DEVICE, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE STRETCHING OF THE COIL. PROCEDURAL/CLINICAL FACTORS LEADING TO ANCHORING OF THE DEVICE DURING REPOSITIONING MAY HAVE CONTRIBUTED TO THE STRETCHING OF THE COIL. WITH REVIEW OF THE AVAILABLE INFORMATION, THE ANALYSIS OF THE RETURNED DEVICE, AND DEVICE HISTORY RECORDS THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES. A DEFINITIVE ROOT CAUSE CONCLUSION CANNOT BE MADE; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE PRESIDIO 10 CERECYTE MICROCOIL 5 MM X 17 CM (PC410051730/M10516) WAS STRETCHED. THE COIL DID NOT COMPLETELY FILL THE ANEURYSM. WHEN THE COIL WAS WITHDRAWN TO RE-FILL, IT WAS FOUND TO BE STRETCHED. THE COIL WAS WITHDRAWN AND CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. THE COIL REMAINED ATTACHED TO THE DELIVERY SYSTEM WHEN IT WAS WITHDRAWN. THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT/REPOSITIONING/WITHDRAWAL OF THE COIL THROUGH THE MICROCATHETER. COIL ENTANGLEMENT WITH PREVIOUSLY PLACED COILS WAS NOT SUSPECTED TO CONTRIBUTE TO THE EVENT. THIS IS NOT A POTENTIAL ADVERSE EVENT. THE TARGET SITE WAS PCOM. THE SIZE WAS 5.35-8.34MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134610 PRESIDIO 10 - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA M10516

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR