BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOX SV PTA CATHETER

    MDR report key: 1202215 · Received October 16, 2008

    Report

    Report Number
    9710478-2008-00139
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 25, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    LIT
    PMA / PMN Number
    K062843
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. WITHOUT THE DEVICE TO EXAMINE, NO DETERMINATION CAN BE MADE AS TO THE ROOT CAUSE OF THE REPORTED EVENT. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITY, WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: BALLOON RUPTURE. TIME OF MALFUNCTION: DURING PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING A RIGHT SUPERFICIAL FEMORAL ARTERY STENTING PROCEDURE, THERE WAS A BALLOON RUPTURE. THE TARGET LESION WAS 99% STENOSED AND HEAVILY CALCIFIED. DUE TO THE CALCIFICATION, THERE WAS SLIGHT RESISTANCE FELT DURING DELIVERY OF THE FOX SV, BUT IT SUCCESSFULLY CROSSED. HOWEVER, DURING BALLOON INFLATION, A RUPTURE WAS OBSERVED. THE ENTIRE BALLOON WAS REMOVED OUT OF THE PT WITH NO FRAGMENTS REMAINING INSIDE THE PT. ANOTHER FOX SV WAS USED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED WITH THE IMPLANTATION OF A NON-ABBOTT STENT. THERE WERE NO ADVERSE PT EFFECTS REPORTED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOX SV PTA CATHETER LIT ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 484365

    Patients

    Seq Age Sex Outcome Treatment
    1 SMART STENT