BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI-TIP POLLAKC OPEN-END URETERAL CATHETER

    MDR report key: 1337050 · Received March 6, 2009

    Report

    Report Number
    1825146-2009-00006
    Event Type
    Injury
    Date Received
    March 6, 2009
    Manufacturer
    COOK UROLOGICAL INC.
    Product Code
    EYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE SPECIMEN JAR WITH SEVERAL SHAVINGS FROM A URETERAL CATHETER WAS RECEIVED; THE CATHETER WAS NOT RETURNED. SIX SEPARATE SHAVINGS WERE RECEIVED; HOWEVER, THE ACTUAL LENGTH OF ALL THE SHAVINGS COULD NOT BE POSITIVELY DETERMINED BECAUSE THE SEGMENTS WERE ACCORDION IN APPEARANCE. DUE TO THE CATHETER NOT BEING RETURNED FOR EVALUATION, WE ARE UNABLE TO DETERMINE WHAT PORTION OF THE CATHETER THE SHAVINGS ORIGINATED FROM AS WELL AS IF ALL THE FRAGMENTS WERE REMOVED; HOWEVER, THE CUSTOMER INDICATED ALL SEGMENTS WERE REMOVED FROM THE PATIENT'S BLADDER DURING THE SAME PROCEDURE. THE CATHETER HAS MOST LIKELY BEEN DAMAGED BY AN INSTRUMENT OF UNDETERMINED ORIGIN CAUSING THE DIFFICULTY EXPERIENCED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE FORWARDED.

    Description of Event or Problem · 1

    DURING A SURGERY, THE CATHETER FELL APART INSIDE THE PATIENT. IT TOOK ABOUT 15-20 MINUTES TO RETRIEVE. CAME OUT OF THE CATHETER IN ONE PIECE BUT WHEN RETRIEVING THE FRAGMENT, IT SEPARATED INTO SEVERAL PIECES. THE SHAVINGS WERE REMOVED FROM THE PATIENT'S BLADDER USING A SMALL ALLIGATOR LIKE FORCEP. ALL FRAGMENTS REMOVED DURING THE SAME PROCEDURE. FIBEROPTIC LASER WIRE PLACED THROUGH THE CATHETER. SHAVINGS ARE FROM THE INSIDE OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXI-TIP POLLAKC OPEN-END URETERAL CATHETER EYB CATHETER, URETERAL, GASTRO-UROLOGY EYB COOK UROLOGICAL INC. U1662925S

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention