BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESIDIO 18 - CERECYTE MICROCOIL

    MDR report key: 2924760 · Received January 22, 2013

    Report

    Report Number
    2954740-2013-00019
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 28, 2012
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K062036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE PROCEDURE OF THE SPLENIC ARTERY, THE PRESIDIO MICROCOIL ((B)(4)) STRETCHED IN THE TRANSIT 2 (MC) MICROCATHETER (CATALOGUE AND LOT NUMBER UNKNOWN) DURING REPOSITIONING. THE COIL WAS ATTEMPTED TO BE DELIVERED TO THE TARGET SITE, BUT WHEN PULLING AND PUSHING THE COIL FOR SEVERAL TIMES, THE COIL UNRAVELED. THEREFORE, BOTH THE ENTIRE COIL AND THE MICROCATHETER WERE SAFELY REMOVED FROM THE PATIENT AS A UNIT. THEN, THE PRESIDIO WAS REPLACED FOR A NEW ONE (LOT UNKNOWN) WHICH WAS MADE ALL WAY THROUGH THE SAME TRANSIT 2. DURING INSERTION, CONSTANT FLUOROSCOPY WAS PERFORMED. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. NO PATIENT INJURY/COMPLICATION WAS REPORTED. 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 ANEURYSM OR IN THE MICROCATHETER. IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. THE VESSEL WAS MODERATELY CALCIFIED AND MODERATELY TORTUOUS. THE COMPLAINT PRODUCT IS UNAVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE. 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. ALTHOUGH A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED, ADDITIONALLY WITHOUT THE DEVICE THE EVENT COULD NOT BE CONFIRMED. IT APPEARS THAT PROCEDURAL FACTORS INCLUDING DEVICE INTERACTION AND DEVICE MANIPULATION MAY HAVE CONTRIBUTED TO THE EVENT. 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.

    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. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS, AND ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, WHILE REPOSITIONING THE PRESIDIO MICROCOIL ((B)(4)) WAS REQUIRED ONCE THE COIL WAS DELIVERED TO THE TARGET SITE, BUT WHEN PULLING AND PUSHING THE COIL FOR SEVERAL TIMES, THE COIL UNRAVELED INTO AN UNSPECIFIED TRANSIT 2 (CATALOG AND LOT NUMBER UNKNOWN). THEREFORE, BOTH THE ENTIRE COIL AND THE MICROCATHETER WERE SAFELY REMOVED FROM THE PATIENT AS A UNIT. THEN, THE PRESIDIO WAS REPLACED FOR A NEW ONE (LOT UNKNOWN) WHICH WAS MADE ALL WAY THROUGH THE SAME TRANSIT 2. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. NO PATIENT INJURY/COMPLICATION WAS REPORTED. 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 ANEURYSM OR IN THE MICROCATHETER. IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. THE PROCEDURE WAS COIL EMBOLIZATION OF SPLENIC ARTERY ANEURYSM THAT WAS MODERATELY CALCIFIED AND MODERATELY TORTUOUS. THE COMPLAINT PRODUCT IS UNAVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30560 PRESIDIO 18 - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA C12485

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR TRANSIT 2 MICROCATHETER