BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASHMERE 14 - CERECYTE MICROCOIL

    MDR report key: 3002918 · Received March 13, 2013

    Report

    Report Number
    1226348-2013-20045
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 6, 2013
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K072173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE EVENT HAPPENED DURING THE PROCEDURE. TWO CASHMERE COILS WERE INVOLVED IN THE COMPLAINT, WHICH OCCURRED DURING A TRANSVENOUS COIL EMBOLIZATION FOR A CAROTID CAVERNOUS SINUS FISTULA VIA THE RIGHT SUPERIOR ORBITAL VEIN THAT WAS MILDLY CALCIFIED AND MILDLY TORTUOUS. BOTH COILS WERE DELIVERED VIA AN EXCELSIOR SL-10 MICROCATHETER, TYPE UNKNOWN (STRYKER). (B)(4): THE FIRST CASHMERE 14 CERECYTE MICROCOIL 3 MM X 6 CM ((B)(4)) WAS FINALLY DETACHED AND SUCCESSFULLY PLACED IN THE TARGET LESION AFTER THE DETACHMENT BUTTON WAS PRESSED APPROXIMATELY 20 TIMES. (B)(4): THE SECOND CASHMERE 14 CERECYTE MICROCOIL 3 MM X 6 CM ((B)(4)) WAS GENTLY PULLED INTO THE MICROCATHETER AFTER IT FAILED TO DETACH. IT DETACHED WITHIN THE MICROCATHETER, AND THEN THE ENTIRE MICROCOIL WAS SAFELY PUSHED INTO THE TARGET LESION USING THE DPU. IT IS UNKNOWN HOW MANY TIMES THE DETACHMENT WAS ATTEMPTED FOR THIS COIL. THE TYPE OF DETACHMENT CONTROL BOX AND CABLE USED WITH THE 2 COMPLAINT PRODUCTS WERE NOT PROVIDED. IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. THE COMPLAINT PRODUCTS WERE NEW AND WERE 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 DEFECTS (KINK, BENDS ETC) WERE NOTED ON THE PRODUCTS BY VISUAL INSPECTION. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED AND NO ISSUES WERE NOTED. ALSO NO DAMAGE WAS REPORTED ON THE DEVICE AFTER THE EVENT. IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. AFTER THE TWO COMPLAINT PRODUCTS, SEVEN ADDITIONAL COILS (CASHMERE, SIZE AND LOT ALL UNKNOWN) WERE SUCCESSFULLY PLACED IN THE TARGET LESION WITH NO FURTHER ISSUES, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. THE COMPLAINT PRODUCTS ARE UNAVAILABLE FOR EVALUATION. HOWEVER, A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH EACH OF THESE LOTS PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT CORRECTIVE ACTION IS WARRANTED AT THIS TIME. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: CASHMERE 14 CERECYTE MICROCOIL 3 MM X 6 CM ((B)(4)), MICROCATHETER (EXCELSIOR SL10/STRYKER, TYPE UNKNOWN), SEVEN COILS (CASHMERE, SIZE AND LOT ALL UNKNOWN).

    Description of Event or Problem · 1

    THE EVENT HAPPENED DURING THE PROCEDURE. TWO COILS: CASHMERE 14 CERECYTE MICROCOIL 3 MM X 6 CM ((B)(4)) AND CASHMERE 14 CERECYTE MICROCOIL 3 MM X 6 CM ((B)(4)) COULD NOT BE DETACHED ALTHOUGH THE DETACHMENT BUTTON WAS PRESSED. THE CASHMERE 14 CERECYTE MICROCOIL 3 MM X 6 CM ((B)(4)) WAS FINALLY DETACHED AND SUCCESSFULLY PLACED IN THE TARGET LESION AFTER THE DETACHMENT BUTTON WAS PRESSED ABOUT 20 TIMES. THE CASHMERE 14 CERECYTE MICROCOIL 3 MM X 6 CM ((B)(4)) WAS GENTLY PULLED INTO AND DETACHED WITHIN THE MICROCATHETER (EXCELSIOR SL10/STRYKER, TYPE UNKNOWN) AND THE ENTIRE MICROCOIL WAS SAFELY PUSHED INTO THE TARGET LESION USING THE DPU. IT IS UNKNOWN HOW MANY TIMES THE DETACHMENT WAS ATTEMPTED. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. THE TYPE OF DETACHMENT CONTROL BOX AND CABLE USED WITH THE PRODUCTS WERE NOT PROVIDED. THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. AFTER THE COMPLAINT PRODUCT, SEVEN COILS (CASHMERE, SIZE AND LOT ALL UNKNOWN) WERE SUCCESSFULLY PLACED IN THE TARGET LESION WITH NO FURTHER ISSUES. THE COMPLAINT PRODUCTS WERE NEW AND WERE 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. PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED AND NO ISSUES WERE NOTED. ALSO NO DAMAGES WERE REPORTED ON THE DEVICE AFTER THE EVENT. THERE WAS NO STRETCHING OR UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. THE COMPLAINT PRODUCTS ARE UNAVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PROCEDURE WAS TRANSVENOUS COIL EMBOLIZATION FOR CAROTID CAVERNOUS SINUS FISTULA VIA RIGHT SUPERIOR ORBITAL VEIN THAT WAS MILDLY CALCIFIED AND MILDLY TORTUOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104814 CASHMERE 14 - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA C10166

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR