BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA BRITE TIP GUIDING CATHETERS

    MDR report key: 1022755 · Received March 28, 2008

    Report

    Report Number
    9616099-2008-00804
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 29, 2008
    Report Date
    February 29, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K021593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVAL AS THE UNIT WAS DISCARDED BY THE FACILITY AS THE PT PRESENTED AN INFECTIOUS DISEASE. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DIFFICULTY ENCOUNTERED WHILE REMOVING THE CATHETER FROM THE PATIENT. THE REPORT RECEIVED INDICATED THAT THE 6F BRITE TIP CATHETER WAS BEING DELIVERED TO THE TARGET VESSEL; HOWEVER, TORQUE WAS APPLIED, SLIGHTLY, TO ENGAGE IT TO THE TARGET VESSEL; THE CATHETER KINKED APPROXIMATELY 40 CM FROM THE PROXIMAL END. THE PHYSICIAN RETRIEVED THE CATHETER FROM THE PATIENT BUT ENCOUNTERED SOME DIFFICULTY WITHDRAWING. A DIFFERENT BRITE TIP CATHETER WAS ENGAGED TO THE TARGET VESSEL WITHOUT PROBLEM AND SUCCESSFUL STENTING OF THE TARGET LESION WAS CONDUCTED. THE PROCEDURE WAS FINISHED SUCCESSFULLY WITHOUT ANY INJURY TO THE PATIENT. FURTHER INFO INDICATED THAT THERE WAS NO EXCESSIVE FORCE USED DURING THE PROCEDURE. HOWEVER, IT WAS INDICATED THAT DUE TO THE KINK IN THE CATHETER, THE PHYSICIAN ENCOUNTERED DIFFICULTY REMOVING IT FROM THE VESSEL. THE TARGET VESSEL WAS THE LEFT POSTERIOR DESCENDING (PDA); THE DE NOVO LESION WAS DESCRIBED AS MODERATELY TORTUOUS WITHOUT CALCIFICATION AND PRESENTING 90% STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISTA BRITE TIP GUIDING CATHETERS CARDIOLOGY GUIDING CATHETERS (DQY) DQY CORDIS DE MEXICO NA 13331067

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR RUNTHROUGH GUIDEWIRE| 6F RADIFOCUS SHEATH