BEUDAMED
    FDA Adverse Event Other Summary report: N

    OVER-THE-WIRE EMBOLECTOMY CATHETER

    MDR report key: 1021078 · Received March 25, 2008

    Report

    Report Number
    1220948-2008-00004
    Event Type
    Other
    Date Received
    March 25, 2008
    Date of Event
    February 19, 2008
    Report Date
    March 17, 2008
    Manufacturer
    LEMAITRE VASCULAR
    Product Code
    DXE
    PMA / PMN Number
    K022145
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OUR FACILITY FOR EVALUATION. AFTER THE DEVICE WAS DECONTAMINATED, IT WAS EVALUATED FOR THE REPORTED COMPLAINT MADE BY THE HOSPITAL. IT WAS CONFIRMED THAT THE CATHETER EXTRUSION AND TIP SEPARATED. THE CATHETER WAS NOTICEABLY STRETCHED WHEN EVALUATED. IT REMAINS UNK WHETHER THE PT EXHIBITED AN EXCESSIVE AMOUNT OF PLAQUE WHICH MAY HAVE CONTRIBUTED TO THE ACUTE FRACTURE OF THE CATHETER. FROM FURTHER INVESTIGATION GIVEN BY THE HOSPITAL, IT WAS STATED THAT THE CATHETER WAS BEING USED FOR A THROMBECTOMY PROCEDURE FOR A DIALYSIS TREATMENT. THE PHYSICIAN STATED "THE PT IS DOING FINE AND THE TIP HAS BEEN SUCCESSFULLY RETRIEVED." "THE CATHETER WAS STRETCHED, BUT BROKE WITHOUT EXERTING AN UNUSUAL FORCE." A LOT HISTORY INVESTIGATION WAS PERFORMED ON LOT OTW1295. IT WAS FOUND THAT THERE WERE NO NON-CONFORMITIES FOUND DURING THE MFR OF THIS PARTICULAR LOT. QC POST-STERILIZATION PULL TESTING WAS PERFORMED AND RETRIEVED. THE LOT WAS FOUND TO PASS WELL ABOVE CURRENT PULL TESTING SPECIFICATIONS. THE ROOT CAUSE OF THE DEVICE COMPLAINT REMAINS INCONCLUSIVE AT THIS TIME.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE CATHETER BROKE INSIDE THE PT. AN ADDITIONAL INCISION WAS MADE TO RETRIEVE THE TIP FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVER-THE-WIRE EMBOLECTOMY CATHETER OTW EMBOLECTOMY CATHETER DXE LEMAITRE VASCULAR 1651-64 OTW1295

    Patients

    Seq Age Sex Outcome Treatment
    1 Other