BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESIDIO 10 - CERECYTE MICROCOIL

    MDR report key: 3973217 · Received August 1, 2014

    Report

    Report Number
    1226348-2014-00168
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 9, 2014
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K002056
    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 BOTH LOTS OF COILS ALLEGED IN THIS EVENT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES THAT CAN BE RELATED TO THE REPORTED COMPLAINT.BASED ON THE INFORMATION, THE EVENT COULD NOT BE CONFIRMED. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS; HOWEVER REVIEWS OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THE LOTS 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 COIL EMBOLISATION OF AN UNKNOWN ANEURYSM LOCATED AT THE PATIENT¿S INTERNAL ILIAC ARTERY THE PHYSICIAN FELT SEVERE RESISTANCE WITH TWO PRESIDIO 10 COILS (PC4100730-30/C12600 AND PC4100626-30/C18314) THROUGH THE PROWLER SELECT PLUS MICROCATHETER (LOT UNKNOWN) AND NOTED THAT THE SECOND COIL DETACHED WHEN IT WAS REMOVED. THE LEVEL OF CALCIFICATION AND THE TORTUOUSITY OF THE VESSEL WERE UNKNOWN. AFTER THE MICROCATHETER REACHED TO THE TARGET LESION SITE, THE PHYSICIAN INSERTED A PRESIDIO COIL (PC4100730-30/C12600) INTO THE MICROCATHETER. HOWEVER, WHILE ADVANCING THE COIL, THE PHYSICIAN EXPERIENCED SEVERE RESISTANCE, THUS THE COIL WAS REMOVED. THE PHYSICIAN THEN CHOSE ANOTHER PRESIDIO COIL (PC4100626-30/C18314) AS THE REPLACEMENT. HOWEVER, WHILE INSERTING THE COIL IN THE INTRODUCER, THE PHYSICIAN EXPERIENCED SEVERE RESISTANCE AGAIN. WHEN THE COIL WAS REMOVED WITH THE INTRODUCER, THE COIL WAS ALREADY DETACHED. A COIL (LOT UNKNOWN) WAS USED TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME MICROCATHETER WITHOUT ANY FURTHER ISSUES. IT IS UNKNOWN AS TO WHETHER THERE WAS A CLINICALLY SIGNIFICANT DELAY TO THE PROCEDURE HOWEVER THERE WAS ALSO NO PATIENT INJURY/COMPLICATION REPORTED. THE ENPOWER DETACHMENT CONTROL BOX (LOT UNKNOWN) WAS USED FOR THE PROCEDURE. 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. ALSO NO DAMAGES WERE REPORTED ON THE DEVICES AFTER THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. THE COMPLAINED PRODUCTS WILL NOT BE RETURNED FOR THE EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451363 PRESIDIO 10 - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA C18314

    Patients

    Seq Age Sex Outcome Treatment
    1