BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOX SV PTA CATHETER

    MDR report key: 1052946 · Received May 27, 2008

    Report

    Report Number
    9710478-2008-00058
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 2, 2008
    Manufacturer
    ABBOTT VASCULAR SWITZERLAND
    Product Code
    LIT
    PMA / PMN Number
    K062843
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: TIP DETACHMENT. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING AN INTERVENTIONAL PROCEDURE OF AN UNSPECIFIED ARTERY, THE FOX SV WAS USED OVER A 0.018 GUIDE WIRE, BUT COULD NOT BE ADVANCED. THE CATHETER WAS REMOVED AND IT WAS NOTED THAT THE RADIOPAQUE TIP HAD DETACHED AND REMAINED ON THE GUIDEWIRE IN THE SHEATH. THE PHYSICIAN REMOVED THE GUIDE WIRE AND THE SHEATH FROM THE PT'S ANATOMY AND SUCCESSFULLY RETRIEVED THE DETACHED TIP FROM THE SHEATH WITHOUT INCIDENT. THERE WAS NO REPORTED ADVERSE PT EFFECT. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOX SV PTA CATHETER LIT ABBOTT VASCULAR SWITZERLAND NA 487826

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK