BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPAQ - CERECYTE MICROCOIL

    MDR report key: 2971877 · Received February 21, 2013

    Report

    Report Number
    1226348-2013-20027
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 6, 2013
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K080437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. BASED ON THE AVAILABLE INFORMATION AND WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, NO ROOT CAUSE CONCLUSION CAN BE MADE. 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.

    Description of Event or Problem · 1

    DURING THE COIL EMBOLIZATION PROCEDURE FOR DISSECTING VERTEBRAL ARTERY, IT WAS NOTED THAT THE DELTAPAQ MICROCOIL (CDF100510-30/G13741) WOULD NOT DETACH ALTHOUGH PRESSING THE DETACHMENT BUTTON FOR ABOUT 10 TIMES. TYPE OF THE DETACHMENT CONTROL BOX AND CABLE USED WITH THE PRODUCT WERE NOT PROVIDED. AFTER REPLACING THE DELTAPAQ FOR A NEW PRODUCT (CDF100510-30, LOT UNKNOWN), THE COIL WAS DETACHED WITHOUT ANY PROBLEM. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. IT IS UNKNOWN IF BOTH THE DETACHMENT CONTROL BOX AND THE CABLE WERE REPLACED OR NOT. IT IS ALSO UNKNOWN HOW MANY COILS WERE PLACED DURING THE PROCEDURE. THE 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. PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED AND NO ISSUES WERE NOTED. THERE WAS NO STRETCHING OR UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER (BRAND NAME AND TYPE UNKNOWN). IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. NO INFORMATION REGARDING THE VESSEL WAS PROVIDED. THE COMPLAINT PRODUCT IS UNAVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75830 DELTAPAQ - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA G13741

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN CABLE AND DCB