BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPLUSH - CERECYTE MICROCOIL

    MDR report key: 2770417 · Received October 3, 2012

    Report

    Report Number
    2954740-2012-00717
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 6, 2012
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K083646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; THEREFORE, A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. WITHOUT THE RETURN OF THE DEVICE, NO CONCLUSION CAN BE MADE REGARDING THE RELATIONSHIP OF THE DEVICE TO THE REPORTED EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. NOTE: ADDITIONAL INFORMATION AND EVALUATION CODES WILL BE SUBMITTED WITHIN 30 DAYS.

    Additional Manufacturer Narrative · 1

    DURING A COIL EMBOLIZATION OF BASILAR ARTERY-ANTERIOR INFERIOR CEREBELLAR ARTERY RUPTURED ANEURYSM WITH MILD VESSEL CALCIFICATION AND TORTUOSITY, SEVERE RESISTANCE WAS ENCOUNTERED WHILE ADVANCING A DELTAPLUSH (CPL100152-30/(B)(4)) IN AN EXCELSIOR SL10 MICROCATHETER. THE RESISTANCE OCCURRED WHEN HALF OF THE EMBOLIC COIL EXPOSED FROM THE MICROCATHETER TIP; IT COULD NOT BE PUSHED ANY FURTHER. THEREFORE, BOTH THE MICROCATHETER AND THE DELTAPLUSH WERE SAFELY WITHDRAWN AS A UNIT. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. PRIOR TO THE ATTEMPT TO PLACE THE DELTAPLUSH, SEVERAL COILS WERE PLACED IN THE ANEURYSM USING THE SAME MICROCATHETER WITHOUT ANY DIFFICULTIES. THE DELTAPLUSH WAS NEW AND WAS 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 PRODUCT BY VISUAL INSPECTION. ALSO NO DAMAGES WERE REPORTED ON THE DEVICE AFTER THE EVENT. THERE WAS NO STRETCHING OR UNINTENDED DETACHMENT OBSERVED IN THE MICROCATHETER. IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. THE DEVICE IS UNAVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PROVIDED LOT NUMBER IS NOT A VALID LOT NUMBER; THEREFORE, A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. WITHOUT THE RETURN OF THE DELTAPLUSH OR THE CONCOMITANT MICROCATHETER, NO CONCLUSION CAN BE MADE REGARDING THE REPORTED INABILITY TO ADVANCE THE DELTAPLUSH ALL THE WAY THROUGH THE MICROCATHETER. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS.

    Description of Event or Problem · 1

    THE PROCEDURE WAS COIL EMBOLIZATION OF BASITAR ARTERY-ANTERIOR INFERIOR CEREBELLAR ARTERY RUPTURED ANEURYSM THAT WAS MILDLY CALCIFIED AND MILDLY TORTUOUS. ACCESS WAS OBTAINED FROM FEMORAL ARTERY. THE EVENT HAPPENED DURING COIL INTRODUCTION. IT WAS NOTED THAT WHILE ADVANCING A DELTAPLUSH (CPL100152-30/C11750, COMPLAINT PRODUCT) IN A MICROCATHETER (EXCELSIOR SL10, TYPE UNKNOWN) , THE PHYSICIAN EXPERIENCED SEVERE RESISTANCE WHEN HALF OF THE EMBOLIC COIL EXPOSED FROM THE MICROCATHETER TIP, AND HE COULD NOT PUSH IT ANY FURTHER. THEREFORE BOTH THE MICROCATHETER AND THE DELTAPLUSH WERE SAFELY WITHDRAWN AS A UNIT. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. PRIOR TO THE COMPLAINT PRODUCT, SEVERAL COILS WERE PLACED IN THE ANEURYSM USING THE SAME MICROCATHETER WITHOUT ANY DIFFICULTIES. THE COMPLAINT PRODUCT WAS NEW AND WAS 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 PRODUCT BY VISUAL INSPECTION. ALSO NO DAMAGES WERE REPORTED ON THE DEVICE AFTER THE EVENT. THERE WAS NO STRETCHING OR UNINTENDED DETACHMENT OBSERVED IN THE MICROCATHETER. IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. THE COMPLAINT PRODUCT IS UNAVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE INDICATED THAT THE COIL DID NOT HERNIATE OUT OF THE SHEATH. THE COIL ACTUALLY GOT STUCK IN THE MICROCATHETER. NO COIL COMPRESSION WAS NOTED POST WITHDRAWAL. NO ADDITIONAL INTERVENTION PERFORMED TO WITHDRAW THE COIL. THE ENTIRE COIL WAS WITHDRAWN AND THE COIL REMAINED ATTACHED TO THE DPU DURING THE PROCESS OF WITHDRAWAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN EXCELSIORSL-10 MICROCATHETER