BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASHMERE 14 - CERECYTE MICROCOIL

    MDR report key: 3142760 · Received June 3, 2013

    Report

    Report Number
    1226348-2013-20106
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 18, 2013
    Report Date
    May 20, 2013
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K072173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A COIL EMBOLIZATION FOR DISSECTION OF RIGHT VERTEBRAL ARTERY THE 12 MM X 30 CM CASHMERE 14 CERECYTE MICROCOIL ((B)(4)) COULD NOT BE DETACHED USING AN ENPOWER CONTROL CABLE ((B)(4)) AND UNKNOWN DETACHMENT CONTROL BOX (DCB) WITH PRESSING THE DETACHMENT BUTTON. TYPE OF THE DCB USED WITH THE PRODUCTS WAS NOT PROVIDED. BOTH THE CABLE AND THE DCB WERE EXCHANGED FOR NEW PRODUCTS (CATALOG AND LOT ALL UNKNOWN); HOWEVER, THE SITUATION DID NOT IMPROVE. THEN, WHEN THE CASHMERE WAS REPLACED FOR A NEW PRODUCT ((B)(4), LOT UNKNOWN) IT WAS ABLE TO BE DETACHED WITH NO FURTHER ISSUES. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. IT IS UNKNOWN HOW MANY COILS WERE SUCCESSFULLY PLACED DURING THE PROCEDURE. THE VESSEL WAS NOT CALCIFIED AND NOT TORTUOUS. THE PRODUCTS WERE NEW AND STORED PER LABELING INSTRUCTIONS. PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED AND NO ISSUES WERE NOTED. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. PRIOR TO USE, NO DEFECT (KINK, BENDS ETC) WAS NOTED ON THE PRODUCTS BY VISUAL INSPECTION. ALSO NO DAMAGES WERE REPORTED ON THE DEVICES AFTER THE EVENT. THE LOW BATTERY LIGHT AND FAULT LIGHT WERE NOT SEEN DURING THE CASE. THE GREEN SYSTEM READY LIGHT ILLUMINATED. IT IS UNKNOWN IF THE DETACHMENT LIGHT ILLUMINATED DURING THE DETACHMENT CYCLE AND IT IS UNKNOWN IF THE AUDIBLE SOUND BEEPED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THERE WAS NO STRETCHING OR UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER (EXCELSIOR SL10/STRYKER, TYPE UNKNOWN). THE DEVICES ARE UNAVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE. ALTHOUGH THE IMPACT OF THE CONTROL CABLE AND DCB ON THE EVENT CANNOT BE DETERMINED WITHOUT THE RETURN OF THE DEVICES, IT WAS REPORTED THAT THE COIL DID NOT DETACH WITH OTHER CONCOMITANT DEVICES WHICH WERE THEN USED SUCCESSFULLY WITH SUBSEQUENT COILS. BASED ON THE REPORT THAT THE PRE-DEPLOYMENT CHECK WAS PERFORMED WITH NO ANOMALIES, IT IS POSSIBLE THAT PROCEDURAL FACTORS MAY HAVE IMPACTED THE FAILURE TO DETACH; HOWEVER, WITHOUT THE RETURN OF THE INVOLVED DEVICES FOR ANALYSIS, NO ROOT CAUSE CONCLUSION CAN BE MADE. (B)(4). A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH CASHMERE LOT C13282 PRESENTED WITH O 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. (B)(4). A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH ENPOWER CONTROL CABLE LOT C13059 PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED FOR THE DCB AS THE LOT NUMBER IS NOT KNOWN. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: ENPOWER CONTROL CABLE ((B)(4)), NEW CABLE (DETAILS UNKNOWN) 2 DETACHMENT CONTROL BOX (DETAILS UNKNOWN), NEW CASHMERE COIL ((B)(4), LOT UNKNOWN), MICROCATHETER (EXCELSIOR SL10/STRYKER, TYPE UNKNOWN).

    Description of Event or Problem · 1

    THE EVENT HAPPENED DURING THE PROCEDURE. IT WAS NOTED THAT THE PHYSICIAN COULD NOT DETACH A CASHMERE ((B)(4)) USING AN ENPOWER CONTROL CABLE ((B)(4)) ALTHOUGH PRESSING THE DETACHMENT BUTTON. TYPE OF THE DETACHMENT CONTROL BOX USED WITH THE PRODUCTS WAS NOT PROVIDED. ALTHOUGH HE REPLACED BOTH THE CABLE AND THE DETACHMENT CONTROL BOX FOR NEW PRODUCTS (CATALOG AND LOT ALL UNKNOWN), THE SITUATION DID NOT IMPROVE. THEN, WHEN THE CASHMERE WAS REPLACED FOR A NEW PRODUCT ((B)(4), LOT UNKNOWN), HE WAS ABLE TO DETACH IT WITH NO FURTHER ISSUES. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. IT IS UNKNOWN HOW MANY COILS WERE SUCCESSFULLY PLACED DURING THE PROCEDURE. THE PRODUCTS WERE NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. PRIOR TO USE, NO DEFECT (KINK, BENDS ETC) WAS NOTED ON THE PRODUCTS BY VISUAL INSPECTION. ALSO NO DAMAGES WERE REPORTED ON THE DEVICES AFTER THE EVENT. PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED AND NO ISSUES WERE NOTED. THE LOW BATTERY LIGHT AND FAULT LIGHT WERE NOT SEEN DURING THE CASE. THE GREEN SYSTEM READY LIGHT ILLUMINATED. IT IS UNKNOWN IF THE DETACHMENT LIGHT ILLUMINATED DURING THE DETACHMENT CYCLE AND IT IS UNKNOWN IF THE AUDIBLE SOUND BEEPED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THERE WAS NO STRETCHING OR UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER (EXCELSIOR SL10/STRYKER, TYPE UNKNOWN). THE COMPLAINT PRODUCTS ARE UNAVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PROCEDURE WAS COIL EMBOLIZATION FOR DISSECTION OF RIGHT VERTEBRAL ARTERY THAT WAS NOT CALCIFIED AND NOT TORTUOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245121 CASHMERE 14 - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA C13282

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR