BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 1299521 · Received December 11, 2008

    Report

    Report Number
    1058196-2008-00287
    Event Type
    Malfunction
    Date Received
    December 11, 2008
    Date of Event
    November 23, 2008
    Report Date
    November 23, 2008
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PATIENT (UNKNOWN DEMOGRAPHICS AND TARGET VESSEL CHARACTERISTICS) UNDERWENT A COIL EMBOLIZATION, AND SOON AFTER THE DELIVERY TUBE (COMPLAINT PRODUCT) WAS INSERTED INTO THE MICROCATHETER (SL-10, BOSTON SCIENTIFIC), THE PHYSICIAN FELT ODD AND PULLED BACK THE DELIVERY TUBE SLOWLY AND CAREFULLY FROM THE PATIENT. UPON REMOVAL, THE COIL WAS FOUND ALREADY STRETCHED. EVENTUALLY THE PROCEDURE WAS COMPLETED USING OTHER COILS. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. ADDITIONAL INFORMATION INDICATED THAT PRIOR TO INSERTING IN THE PATIENT, NONE OF PRODUCTS WAS DAMAGED. DURING DELIVERY, ALL (IFU) INSTRUCTION FOR USE GUIDELINES WAS FOLLOWED. AFTER THE PRODUCT WAS REMOVED FROM THE PATIENT, THE ENTIRE UNRAVELED/STRETCHED COIL WAS REMOVED FROM THE PATIENT. BESIDES THE COIL UNRAVELED/STRETCHED CONDITION, NO OTHER DAMAGES WERE NOTED WITH THE SYSTEM. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFILL DCS ORBIT MINI COMPLEX FILL CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA 13336040

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SL-10