BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESIDIO - CERECYTE MICROCOIL

    MDR report key: 4201706 · Received October 27, 2014

    Report

    Report Number
    2954740-2014-50018
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 30, 2014
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K062036
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ENPOWER CONTROL CABLE ((B)(4)) ENPOWER CONTROL CABLE ((B)(4)) EXCELSIOR SL-10 MICROCATHETER (STRYKER, TYPE UNKNOWN) BASED ON THE INFORMATION, THE EVENT COULD NOT BE CONFIRMED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED BECAUSE THE LOT FOR THE PRODUCT IS UNKNOWN. SINCE THE EVENT COULD NOT BE CONFIRMED AND THERE IS NO EVIDENCE OF A MANUFACTURING-RELATED MALFUNCTION, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING EMBOLIZATION OF A SUBARACHNOID HEMORRHAGE (SAH) AT THE PATIENT¿S BASILAR ARTERY TIP THE PHYSICIAN WAS NOT ABLE TO DETACH THE PRESIDIO COIL (DETAILS UNKNOWN) WITH AN ENPOWER CONTROL CABLE ((B)(4)). THE ARTERY WAS NOT TORTUOUS AND NOT CALCIFIED. IT WAS REPORTED THAT AN EXCELSIOR SL-10 MICROCATHETER (STRYKER, TYPE UNKNOWN) WAS ALSO USED FOR THE ABOVE PROCEDURE. NO FURTHER DETAILS OF THE CONCOMITANT DEVICES ARE AVAILABLE. THE PHYSICIAN WAS UNABLE TO DETACH THE FIRST PRESIDIO PLACED IN THE TARGET LESION SITE. THE COMPLAINT CABLE WAS REPLACED WITH ANOTHER CABLE (LOT UNKNOWN), AND THE PHYSICIAN WAS ABLE TO DETACH THE COIL. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE OR DELAY. THERE WAS ALSO NO PATIENT INJURY/COMPLICATIONS REPORTED. THE COMPLAINT 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. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. PRIOR TO PRESSING THE DETACH BUTTON THE ENPOWER DEVICES DID NOT SHOW ANY ABNORMAL BEHAVIOR. ALSO NO DAMAGES WERE REPORTED ON THE CONCOMITANT DEVICES AFTER THE EVENT. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681502 PRESIDIO - CERECYTE MICROCOIL CNV DCS COILS HCG CODMAN AND SHURTLEFF, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1