BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE LUMEN HEPARIN COATED CENTRAL VENOUS CATHETER SET

    MDR report key: 1810584 · Received August 11, 2010

    Report

    Report Number
    1820334-2010-00375
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    February 24, 2010
    Report Date
    July 14, 2010
    Manufacturer
    COOK INC.
    Product Code
    FOZ
    PMA / PMN Number
    K033843
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT WAS RETURNED IN A USED AND DAMAGED CONDITION. THIS DEVICE IS INSPECTED 100% FOR BENDS, KINKS, ADEQUATE JOINT STRENGTH, CORRECT OUTSIDE DIMENSION AND OTHER SURFACE IMPERFECTIONS PRIOR TO TRANSPORT. AN EXAMINATION OF THE RETURNED SEGMENT FOUND THE DISTAL WELD CONNECTION TO BE INTACT AS WELL AS THE SAFETY WIRE TO MANDREL WIRE CONNECTION. THE WIRE GUIDE ITSELF HAS SEPARATED. NO ELONGATION APPEARS TO BE PRESENT. WITHOUT ANY APPARENT ELONGATION OF THE COIL WIRE, IT DOES NOT APPEAR AS IF THE SEPARATION IS DUE TO EXCESSIVE FORCE APPLIED; RATHER THE MOST LIKELY CAUSE OF THIS SEPARATION WAS THE WIRE GUIDE BEING CUT BY THE NEEDLE BEVEL OR OTHER INSTRUMENT. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    A PT HAD A CENTRAL LINE PLACED IN THE RIGHT SUBCLAVIAN VEIN. FOLLOWING INSERTION, A CHEST X-RAY WAS PERFORMED TO CONFIRM PLACEMENT. THE CATHETER WAS CONFIRMED TO BE IN THE SUPERIOR VENA CAVA; HOWEVER, A LOOP OF A GUIDE WIRE WAS SEEN IN THE AREA OF THE RIGHT INTERNAL JUGULAR VEIN. THE PT'S BED WAS SEARCHED FOR ANY STRAY WIRE THAT MIGHT HAVE SHOWN UP ON X-RAY, NONE WAS FOUND. A SECOND X-RAY WAS TAKEN WHICH ALSO SHOWED WIRE IN THE AREA OF THE RIGHT INTERNAL JUGULAR VEIN. THE PT WAS TAKEN TO THE CARDIAC CATHETERIZATION LAB THE FOLLOWING MORNING FOR RETRIEVAL OF THE WIRE. THE GUIDE WIRE WAS RETRIEVED USING A 5 MM SNARE WITHOUT DIFFICULTY. THE GUIDE WIRE APPEARED TO HAVE FRAYED AND BROKEN OFF APPROX 3.5 CM FROM THE CURVED END (J SHAPE). DURING THE CATH LAB PROCEDURE, THE CARDIOLOGIST IDENTIFIED THAT THE PT HAD AN ANOMALOUS LEFT CORONARY ARTERY ARISING FROM THE PULMONARY ARTERY (ALCAPA), AND ENLARGED LEFT ATRIUM AND LEFT VENTRICLE. THE PT WAS TAKEN TO THE OPERATING ROOM AFTERWARDS FOR REPAIR. A PORTION OF THE GUIDEWIRE HAD TO BE SURGICALLY REMOVED FROM THE AREA OF THE PT'S RIGHT INTERNAL JUGULAR VEIN. THE CURRENT STATUS OF THE PT WAS NOT RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOUBLE LUMEN HEPARIN COATED CENTRAL VENOUS CATHETER SET FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ COOK INC. NA 2357904

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Required Intervention