BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-VU SIZING CATHETER

    MDR report key: 1080087 · Received July 17, 2008

    Report

    Report Number
    1319211-2008-00030
    Event Type
    Malfunction
    Date Received
    July 17, 2008
    Date of Event
    May 21, 2008
    Report Date
    July 10, 2008
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    DQO
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED LOT HISTORY RECORD WAS REVIEWED FOR ANY ABNORMALITIES WHICH, MAY HAVE CONTRIBUTED TO THE CAUSE OF THE COMPLAINT. NOTHING KNOWN TO HAVE CONTRIBUTED TO THE COMPLAINT WAS OBSERVED. THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR EVALUATION. THE COMPLAINT INVESTIGATION IS INCONCLUSIVE. THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE, ANGIODYNAMICS IS UNABLE TO CONDUCT A THOROUGH INVESTIGATION. THE EXACT CAUSE OF THE COMPLAINT IS UNKNOWN. THE INSTRUCTIONS FOR USE LIST THE FOLLOWING STATEMENTS TO HELP PREVENT THIS COMPLAINT TYPE FROM OCCURING: "IF RESISTANCE IS ENCOUNTERED DURING CATHETER MANIPULATION, DETERMINE THE CAUSE UNDER FLUOROSCOPY AND TAKE THE NECESSARY REMEDIAL ACTION. IF RESISTANCE IS ENCOUNTERED WHEN REMOVING THE GUIDEWIRE FROM THE CATHETER, SIMULTANEOUSLY REMOVE THE CATHETER AND THE GUIDEWIRE AS A SINGLE UNIT UNDER FLUOROSCOPY TO PREVENT POTENTIAL VESSEL AND PRODUCT DAMAGE." "ALWAYS USE A GUIDEWIRE TO REMOVE THE CATHETER FROM THE VASCULATURE. FAILURE TO DO SO MAY RESULT IN DAMAGE TO THE VESSEL, THE CATHETER, OR BOTH." "ANGIODYNAMICS ANGIOGRAPHIC CATHETERS ARE DESIGNED FOR USE WITH SPECIFIC GUIDEWIRE DIAMETERS. THE RECOMMENDED MAXIMUM GUIDEWIRE DIAMETER IS SPECIFIED ON THE CATHETER LABEL. GUIDEWIRE USE HAS BEEN ASSOCIATED WITH A GREATER INCIDENCE OF THROMBUS FORMATION. OPTIMAL GUIDEWIRE SIZE AND JUDICIOUS SUE ARE RECOMMENDED." "DO NOT ATTEMPT TO HAND STRAIGHTEN THE TIP OF ANY CURVED TIPPED CATHETER WHICH ARE FURNISHED WITH A TIP STRAIGHTENER. THIS MAY RESULT IN DAMAGE TO THE PRODUCT. TIP STRAIGHTENERS ARE FURNISHED ON ALL CATHETERS INTENDED TO BE STRAIGHTENED WITH THE AID OF A TIP STRAIGHTENER." THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. NO FURTHER ACTION AT THIS TIME. FREQUENCY HAS INCREASED, BUT THE SEVERITY OF THIS EVENT IS NOT GREATER THAN USUAL.

    Description of Event or Problem · 1

    THE PATIENT WAS TAKEN TO THE CATH LAB BY INTERVENTIONAL RADIOLOGY FOR THE PERFORMANCE OF A TIPS (TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC STENT SHUNT) PROCEDURE FOR A MASSIVE VARICEAL HEMORRHAGE. DURING THE PROCEDURE, AN ACCU-VU 70 CM CATHETER WAS USED. FIVE DAYS LATER, A CT SCAN WAS PERFORMED, WHICH AMONG OTHER FINDINGS, A FOREIGN BODY WAS FOUND TO BE LODGED IN THE MAIN PORTAL VEIN. THE PATIENT WAS RETURNED TO THE CATH LAB AND THE PIGTAIL TIP OF THE ACCU-VU CATHETER WAS REMOVED FROM THE MAIN PORTAL VEIN. THE TIP HAD BROKEN OFF FROM THE CATHETER DURING THE INITIAL PROCEDURE AND FOUND TO BE LODGED IN THE VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-VU SIZING CATHETER ANGIOGRAPHIC CATHETER DQO ANGIODYNAMICS, INC. 952222

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR