BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPLUSH - CERECYTE MICROCOIL

    MDR report key: 3950305 · Received July 22, 2014

    Report

    Report Number
    1226348-2014-00158
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 30, 2014
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K083646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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), CATHETER (DETAILS UNKNOWN).

    Additional Manufacturer Narrative · 1

    AFTER THE DEPLOYMENT OF THE DELTAPLUSH CERECYTE MICROCOIL 2 MM X 3 CM (CPL10020330/ C23740), IT WAS STUCK AT THE TIP OF THE CATHETER (DETAILS UNKNOWN). DESPITE MANEUVERS WITH THE GUIDE, IT WASN'T POSSIBLE TO DETACH THE COIL. THE ASSEMBLY (COIL, GUIDE AND CATHETER) HAS BEEN REMOVED. NO CONSEQUENCES TO THE PATIENT. ANOTHER LIKE DEVICE (DETAILS UNKNOWN) WAS USED. NO VESSEL CODE INFORMATION WAS PROVIDED. BASED ON THE INFORMATION, THE EVENT WAS NOT 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.

    Additional Manufacturer Narrative · 1

    CC UPDATED WITH ADDITIONAL INFORMATION: AFTER THE DEPLOYMENT OF THE DELTAPLUSH CERECYTE MICROCOIL 2 MM X 3 CM (CPL10020330/C23740), IT WAS STUCK AT THE TIP OF THE ECHELON 10 EV3 CATHETER (DETAILS UNKNOWN). DESPITE MANEUVERS WITH THE GUIDE, IT WASN'T POSSIBLE TO DETACH THE COIL. THE ASSEMBLY (COIL, GUIDE AND CATHETER) HAS BEEN REMOVED. NO CONSEQUENCES TO THE PATIENT. ANOTHER LIKE DEVICE (DETAILS UNKNOWN) WAS USED. THERE WAS NO RESISTANCE/FRICTION DURING DEPLOYMENT OF THE COIL SYSTEM THROUGH THE MICROCATHETER. THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO DAMAGES NOTED ON THE COIL AFTER USE. THE COIL REMAINED ATTACHED TO THE MICROCATHETER. THE SAME DETACHMENT CONTROL BOX (DETAILS UNKNOWN) AND CONNECTING CABLE (DETAILS UNKNOWN) WERE USED TO COMPLETE THE PROCEDURE. THE LOW BATTERY LIGHT WAS NOT SEEN DURING THE CASE. THE FAULT LIGHT WAS SEEN DURING THE CASE. THE GREEN SYSTEM READY LIGHT ILLUMINATED. DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT ILLUMINATED. THE AUDIBLE SIGNAL BEEPED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THE TARGET VESSEL WAS ANTERIOR COMMUNICATING ARTERY WHICH WAS NOT CALCIFIED AND NOT TORTUOUS. BASED ON THE INFORMATION, THE EVENT WAS NOT 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.

    Additional Manufacturer Narrative · 1

    AFTER THE DEPLOYMENT OF THE DELTAPLUSH CERECYTE MICROCOIL 2 MM X 3 CM (CPL10020330/C23740), IT WAS STUCK AT THE TIP OF THE ECHELON 10 EV3 CATHETER (DETAILS UNKNOWN). DESPITE MANEUVERS WITH THE GUIDE, IT WASN'T POSSIBLE TO DETACH THE COIL. THE ASSEMBLY (COIL, GUIDE AND CATHETER) HAS BEEN REMOVED. NO CONSEQUENCES TO THE PATIENT. ANOTHER LIKE DEVICE (DETAILS UNKNOWN) WAS USED. THERE WAS NO RESISTANCE/FRICTION DURING DEPLOYMENT OF THE COIL SYSTEM THROUGH THE MICROCATHETER. THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO DAMAGES NOTED ON THE COIL AFTER USE. THE COIL REMAINED ATTACHED TO THE MICROCATHETER. THE SAME DETACHMENT CONTROL BOX (DETAILS UNKNOWN) AND CONNECTING CABLE (DETAILS UNKNOWN) WERE USED TO COMPLETE THE PROCEDURE. THE LOW BATTERY LIGHT WAS NOT SEEN DURING THE CASE. THE FAULT LIGHT WAS SEEN DURING THE CASE. THE GREEN SYSTEM READY LIGHT ILLUMINATED. DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT ILLUMINATED. THE AUDIBLE SIGNAL BEEPED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THE TARGET VESSEL WAS ANTERIOR COMMUNICATING ARTERY WHICH WAS NOT CALCIFIED AND NOT TORTUOUS. VISUAL: LIMITED INFORMATION WAS RECEIVED. ONLY THE COIL WAS RETURNED. THE DPU WAS NOT RETURNED. THE ECHELON 10 MICROCATHETER WAS RETURNED WITH A GUIDE WIRE INSIDE. AS VIEWED THROUGH THE RETURNED PACKAGING IT WAS FOUND THAT THE COIL WAS PROTRUDING OUTSIDE THE MICROCATHETER AND THAT THE DPU WAS NOT RETURNED (PHOTO 1 & 2). A GUIDE WIRE WAS RETURNED STUCK INSIDE THE MICROCATHETER (PHOTO 3). MICROSCOPIC: BOTH THE DAMAGED COIL AND THE GUIDE WIRE PROTRUDE OUTSIDE THE MICROCATHETER¿S DISTAL TIP (PHOTO 4 THROUGH 9). THE DISTAL TIP OF THE GUIDE WIRE WAS CLAMPED AND REMOVED WHICH ALSO REMOVED THE COIL (PHOTO 10 & 11). THE COIL WAS FOUND TO BE ADHERING TO THE GUIDE WIRE. NOTE THE COMPRESSION AND BUCKLING DAMAGE TO THE COIL (PHOTO 12 & 13). AFTER CLEANING COIL VIEW (PHOTO 14 & 15) BALL TIP (PHOTO 16). NO ANOMALIES WERE FOUND TO THE MICROCATHETERS INNER DIAMETER. THE MICROCATHETER DOES NOT APPEAR TO HAVE CONTRIBUTED TO THE COMPLAINT EVENT (PHOTO 17). SUMMARY: AS VIEWED THROUGH THE RETURNED PACKAGING IT WAS FOUND THAT THE COIL WAS PROTRUDING OUTSIDE THE DISTAL TIP OF THE MICROCATHETER AND THAT THE DEVICE POSITIONING UNIT (DPU) WAS NOT RETURNED. A GUIDE WIRE WAS RETURNED STUCK INSIDE THE MICROCATHETER. BOTH THE DAMAGED COIL AND THE GUIDE WIRE WERE FOUND PROTRUDING SIDE BY SIDE OUTSIDE THE MICROCATHETER¿S DISTAL TIP. BUCKLING AND COMPRESSION DAMAGE WERE FOUND TO THE PROXIMAL END OF THE DETACHED COIL. DUE TO THE GUIDE WIRE BEING PUSHED BESIDE AND PAST THE COIL INSIDE THE MICROCATHETER BY THE END USER, IT CANNOT BE DETERMINED WHEN THIS DAMAGE OCCURRED TO THE PROXIMAL END OF THE COIL. NO ANOMALIES WERE FOUND TO THE MICROCATHETERS INNER DIAMETER. THEREFORE, WITHOUT THE RETURN OF THE COMPLETE DPU USED IN THE PROCEDURE, IT CANNOT BE DETERMINED HOW OR WHY THE COIL BECAME STUCK AT THE DISTAL TIP OF THE MICROCATHETER, HOW THE UNINTENDED DETACHMENT OCCURRED, AND WHY THE COIL COULD NOT BE DETACHED AS IT WAS STUCK INSIDE THE DISTAL TIP OF THE MICROCATHETER. BASED ON THE INFORMATION AND THE ANALYSIS, THE EVENT COULD NOT BE CONFIRMED, HOWEVER PROCEDURAL FACTORS MAY HAVE CONTRIBUTED 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.

    Description of Event or Problem · 1

    AFTER THE DEPLOYMENT OF THE DELTAPLUSH CERECYTE MICROCOIL 2 MM X 3 CM (CPL10020330/C23740), IT WAS STUCK AT THE TIP OF THE CATHETER (DETAILS UNKNOWN). DESPITE MANEUVERS WITH THE GUIDE, IT WASN'T POSSIBLE TO DETACH THE COIL. THE ASSEMBLY (COIL, GUIDE AND CATHETER) HAS BEEN REMOVED. NO CONSEQUENCES TO THE PATIENT. ANOTHER LIKE DEVICE (DETAILS UNKNOWN) WAS USED. NO VESSEL CODE INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428715 DELTAPLUSH - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA C23740

    Patients

    Seq Age Sex Outcome Treatment
    1