BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOSTENT SELFX SELF-EXPANDING STENT SYSTEM

    MDR report key: 1162236 · Received September 16, 2008

    Report

    Report Number
    9710478-2008-00121
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 4, 2008
    Manufacturer
    ABBOTT VASCULAR SWITZERLAND
    Product Code
    FGE
    PMA / PMN Number
    K050534
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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: PREMATURE, PARTIAL DEPLOYMENT. TIME OF MALFUNCTION: DURING INSERTION. SYMPTOMS/AE: NA. IT WAS REPORTED THAT DURING INSERTION THERE WAS DIFFICULTY ADVANCING THE SELFX STENT DELIVERY SYSTEM (SDS) OVER THE .035 GUIDE WIRE. AS THE SDS WAS BEING REMOVED FROM THE GUIDE WIRE, SO THAT MORE LUBRICANT COULD BE APPLIED TO THE WIRE, THE STENT PREMATURELY, PARTIALLY DEPLOYED, ALTHOUGH THE HANDLE WAS STILL IN THE LOCKED POSITION. THIS OCCURRED OUTSIDE OF THE BODY AND THERE WAS NO PATIENT INVOLVEMENT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT SELFX SELF-EXPANDING STENT SYSTEM FGE ABBOTT VASCULAR SWITZERLAND NA 497322

    Patients

    Seq Age Sex Outcome Treatment
    1 NA .035 SAIG GUIDE WIRE| SHORT 7F SAIG SHEATH