BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASHMERE 14 - PLATINUM MICROCOIL

    MDR report key: 3150325 · Received June 6, 2013

    Report

    Report Number
    1226348-2013-20108
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    March 1, 2013
    Report Date
    May 27, 2013
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K022420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. NO ADDITIONAL INFORMATION IS AVAILABLE. IT WAS ORIGINALLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR EVALUATION; HOWEVER, ADDITIONAL INFORMATION REPORTED THAT THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. WITH REVIEW OF THE AVAILABLE INFORMATION AND WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, NO CONCLUSION CAN BE MADE REGARDING THE ROOT CAUSE OF THE FAILURE OF THE COIL TO DETACH AFTER PASSING PRE-DEPLOYMENT CHECK. 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 AN UNKNOWN VESSEL, THE CASHMERE 14 PLATINUM MICROCOIL (SRC140406-20/F42567) COULD NOT BE DETACHED ALTHOUGH PRESSING THE DETACHMENT BUTTON. TYPE OF BOTH THE DETACHMENT CONTROL BOX AND THE CABLE USED WITH THE PRODUCT WERE NOT PROVIDED. THE CASHMERE WAS REPLACED FOR A NEW PRODUCT (SRC140406-20, LOT UNKNOWN) THAT WAS DETACH WITH NO FURTHER ISSUES WITH THE SAME CABLE AND DCB. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. NO LOW BATTERY LIGHT WAS SEEN DURING CASE OR FAULT LIGHT SEEN DURING THE CASE, AND UPON PRESSING THE POWER BUTTON, ALL LIGHTS ILLUMINATED. ALL CONNECTIONS APPEAR TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE, AND NO RESISTANCE OCCURRED DURING INSERTION, ADVANCEMENT, POSITIONING, OR REMOVAL OF THE COIL DELIVERY SYSTEM. NO ATTEMPTS WERE MADE TO DETACH THE COIL MANUALLY. THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. IT IS UNKNOWN HOW MANY COILS WERE SUCCESSFULLY PLACED DURING THE PROCEDURE. THE PRODUCT WAS 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 PRODUCT BY VISUAL INSPECTION. ALSO NO DAMAGES WERE REPORTED ON THE DEVICE AFTER THE EVENT. 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). NO INFORMATION REGARDING THE VESSEL/ANEURYSM WAS PROVIDED. THE COMPLAINT PRODUCT IS UNAVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251618 CASHMERE 14 - PLATINUM MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA F42567

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN CABLE AND DCB