BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVY CORNUAL CANNULATION SET

    MDR report key: 1151445 · Received September 5, 2008

    Report

    Report Number
    1825146-2008-00029
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 5, 2008
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    MOV
    PMA / PMN Number
    K931476
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED GUIDE CATHETER WAS RECEIVED NOTING THE CATHETER TO BE SEPARATED INTO TWO SEGMENTS NEAR THE BONDED AREA. A SCRAPE MARK WAS OBSERVED ON THE CATHETER STARTING AT THE POINT OF SEPARATION AND CONTINUED TOWARD THE HUB; SEVERAL GOUGES WERE ALSO NOTED NEAR THE POINT OF SEPARATION. THE CUSTOMER INDICATED A 12 DEGREE OLYMPUS HYSTEROSCOPE WITH 5FR WORKING CHANNEL SCOPE WAS USED DURING THE PROCEDURE. UPON EXAMINATION OF THE POINT OF SEPARATION, THE INNER WIRES WERE NOTED TO BE PROTRUDING AND BENT OVER THE END OF THE CATHETER. THIS CATHETER HAS INNER WIRES TO AID THE PHYSICIAN SHOULD THEY WANT TO TURN THE CATHETER TO ASSURE STABILITY. THREE CATHETERS FROM PRODUCTION WERE TEST PULLED AND ALL THREE CATHETERS SEPARATED BEYOND SPECIFICATION. TWO CATHETERS WERE BENT TO APPROX A 90 DEGREE ANGLE BEFORE TEST PULLING IN AN ATTEMPT TO RECREATE THE BENT WIRE APPEARANCE OF THE COMPLAINT PRODUCT NOTING THE INNER WIRES ON ALL THREE CATHETERS WERE STRAIGHT AT THE POINT OF SEPARATION. UNABLE TO DETERMINE WHAT HAS CAUSED THE CUSTOMERS DIFFICULTY, ADD'L INVESTIGATION IS CURRENTLY UNDERWAY. WHEN ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE FORWARDED.

    Description of Event or Problem · 1

    "TIP OF NOVY CATHETER DROPPED OFF INTO THE PT'S UTERUS. TIP OF NOVY CATHETER RETRIEVED HYSTEROSCOPICALLY WITH GRASPERS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVY CORNUAL CANNULATION SET MOV CATHETER, SALPINGOGRAPHY MOV COOK UROLOGICAL, INC. NA U1697762

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention