BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOSHIELD PRO EMBOLIC PROTECTION SYSTEM

    MDR report key: 1220375 · Received October 31, 2008

    Report

    Report Number
    9616695-2008-00154
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 15, 2008
    Manufacturer
    ABBOTT VASCULAR GALWAY
    Product Code
    NTE
    PMA / PMN Number
    K052454
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. THE DEVICE REPORTED IS AN ABBOTT INTERNATIONAL PRODUCT WHICH IS THE SAME OR SIMILAR TO A DEVICE THAT IS MARKETED DOMESTICALLY.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: CATHETER TIP DETACHMENT. TIME OF MALFUNCTION: DURING PREPARATION. SYMPTOMS/AE: NA. IT WAS REPORTED THAT DURING DEVICE PREPARATION, THERE WAS DIFFICULTY BACK LOADING THE LOADED EMBOSHIELD PRO DELIVERY CATHETER ONTO THE WIRE. THE TIP OF THE CATHETER SHAFT DETACHED. THERE WAS NO PATIENT INVOLVEMENT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSHIELD PRO EMBOLIC PROTECTION SYSTEM NTE ABBOTT VASCULAR GALWAY NA 529015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA