BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASHMERE 14 - CERECYTE MICROCOIL

    MDR report key: 3061991 · Received April 16, 2013

    Report

    Report Number
    1226348-2013-20070
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 10, 2013
    Report Date
    March 29, 2013
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K072173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: DURING TREATMENT OF THE 4 MM X 8 CM CASHMERE 14 CERECYTE MICROCOIL HAD MULTIPLE ISSUES STAYING IN THE ANEURYSM, IT WAS REPOSITIONED ABOUT 4 TIMES BUT EACH TIME IT POPPED OUT RIGHT WHEN THE COIL WAS APPROACHING THE DETACHMENT ZONE. IT SEEMED LIKE THE COIL DETACHMENT ZONE WAS TOO STIFF AND UNFORGIVING. FINALLY ONCE WORKED INTO PLACE AN ATTEMPT WAS MADE TO DETACH THE COIL AND IT WOULD NOT DETACH. THE DEVICE WAS THEN SWITCHED TO A COMPETITIVE COIL WHICH SLIDE RIGHT INTO ANEURYSM AND DETACHED WITHOUT ANY PROBLEMS. THE CONNECTING CABLE AND DETACHMENT CONTROL BOX WERE NOT USED WITH ANY COILS AFTER THE EVENT SINCE OTHER COIL SYSTEMS WERE THEN USED. THE TARGET LESION WAS THE POSTERIOR COMMUNICATING ARTERY (PCOM) WITH HIGH VESSEL TORTUOSITY AND UNKNOWN CALCIFICATION. AN SL-10 FROM STRYKER WAS USED WITH THE CASHMERE COIL. THE PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED AND NEITHER THE LOW BATTERY LIGHT NOR FAULT LIGHT WAS SEEN DURING THE CASE. IT COULD NOT BE CONFIRMED IF THE DETACHMENT LIGHT ILLUMINATED DURING THE DETACHMENT CYCLE. THE AUDIBLE SOUND BEEPED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THE SAME CONNECTING CABLE AND DETACHMENT CONTROL BOX WERE NOT USED AFTER THE EVENT; AN ENTIRELY DIFFERENT SYSTEM WAS USED AFTER THE EVENT. THERE WERE NO DAMAGES NOTED ON THE COIL PRIOR TO USE AND NOTHING WAS IDENTIFIED AS DAMAGED POST USE. OTHER PRODUCTS USED WERE CNV COILS, STRYKER COILS, AND ENVOY GUIDE CATHETER. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS. THE CONNECTING CABLE AND DETACHMENT CONTROL BOX USED WITH THE CASHMERE COIL SYSTEM ARE NOT AVAILABLE FOR ANALYSIS AND THE LOT NUMBER IS NOT KNOWN; THEREFORE, THE DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. WITHOUT THE RETURN OF THE INVOLVED DEVICES AND BASED ON THE AVAILABLE INFORMATION, NO CONCLUSION CAN BE MADE REGARDING THE RELATIONSHIP OF THESE DEVICES TO THE INABILITY TO DETACH THE COIL. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. (B)(4) - WITHOUT THE RETURN OF THE CASHMERE COIL SYSTEM NO CONCLUSION CAN BE MADE REGARDING THE DEVICE AND THE POSITIONING DIFFICULTY ENCOUNTERED. ADDITIONALLY WITHOUT THE RETURN OF THIS DEVICE AND THE CONCOMITANT DEVICES, NO CONCLUSION CAN BE MADE REGARDING CONTRIBUTING OR ROOT CAUSE OF THE FAILURE TO DETACH. IT IS POSSIBLE THAT THE HIGHLY TORTUOUS VESSEL CHARACTERISTICS AND REQUIRED DEVICE MANIPULATION MAY HAVE CONTRIBUTED; HOWEVER, NO CONCLUSION CAN BE MADE WITHOUT THE RETURN OF THE DEVICE. 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. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: COMPETITOR COIL (DETAILS UNKNOWN). SL-10 STRYKER MICROCATHER (DETAILS UNKNOWN). CNV COILS (DETAILS UNKNOWN). STRYKER COILS (DETAILS UNKNOWN). ENVOY GUIDE CATHETER (DETAILS UNKNOWN). TWO (2) CONNECTING CABLES (DETAILS UNKNOWN). TWO(2) DETACHMENT CONTROL BOXES (DETAILS UNKNOWN).

    Description of Event or Problem · 1

    CASHMERE 14 CERECYTE MICROCOIL 4 MM X 8 CM (CRC14040830/C12609) HAD MULTIPLE ISSUES STAYING IN THE ANEURYSM, IT WAS REPOSITIONED ABOUT 4 TIMES BUT EACH TIME IT POPPED OUT RIGHT WHEN THE COIL WAS APPROACHING THE DETACHMENT ZONE. IT SEEMED LIKE THE COIL DETACHMENT ZONE WAS TOO STIFF AND UNFORGIVING. FINALLY ONCE WORKED INTO PLACE IT WAS ATTEMPTED TO DETACH BUT IT WOULD NOT DETACH. THE COIL WAS CHANGED TO A COMPETITOR COIL WHICH SLID RIGHT INTO THE ANEURYSM AND DETACHED WITHOUT ANY PROBLEMS. A NEW CONNECTING CABLE AND DETACHMENT CONTROL BOX WERE USED WITH THE COMPETITOR COIL TO COMPLETE THE PROCEDURE. THERE WERE NO DAMAGES NOTED ON THE COIL PRIOR TO AND AFTER USE. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE LOW BATTERY LIGHT AND FAULT LIGHT WERE NOT SEEN DURING THE CASE. IT IS UNKNOWN IF THE DETACHMENT LIGHT ILLUMINATED DURING DETACHMENT. THE AUDIBLE SOUND BEEPED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. AN SL-10 FROM STRYKER WAS USED IN WITH THE COMPLAINT DEVICE. OTHER PRODUCTS USED WERE CNV COILS, STRYKER COILS, AND ENVOY GUIDE CATHETER. TARGET LESION WAS PCOM, VESSEL TORTUOSITY WAS HIGH BUT THE AMOUNT OF CALCIFICATION IS UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS. THERE WAS NO PATIENT DEATH OR SERIOUS INJURY THAT OCCURRED AS A RESULT OF THE EVENT. ADDITIONAL MEDICAL INTERVENTION OR MEDICATION WAS NOT REQUIRED TO PREVENT IMPAIRMENT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163448 CASHMERE 14 - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA C12609

    Patients

    Seq Age Sex Outcome Treatment
    1