BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIONS PV .018

    MDR report key: 1576558 · Received January 12, 2010

    Report

    Report Number
    2939520-2010-00003
    Event Type
    Injury
    Date Received
    January 12, 2010
    Date of Event
    December 14, 2009
    Report Date
    December 14, 2009
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    IYO
    PMA / PMN Number
    K944004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCUMENTATION FOR THIS LOT WAS REVIEWED AND TO DATE, NO COMPLAINTS HAVE BEEN FILED AGAINST IT. THE MANUFACTURING DOCUMENTATION WAS REVIEWED AND THE DEVICE MET ALL THE INSPECTION AND TESTING REQUIREMENTS PRIOR TO RELEASE. NO DISCREPANCIES WERE NOTED THAT COULD HAVE CONTRIBUTED TO THE FAILURE. UPON VISUAL EXAMINATION OF THE DEVICE, IT WAS CONFIRMED THAT THE DISTAL TIP OF THE DEVICE HAD FOLDED OVER ON ITSELF. THE STIFFENING WIRE, WHICH HAD BEEN INTENTIONALLY REMOVED FROM INSIDE THE PV .018 BY THE PHYSICIAN WAS U SHAPED. THE END PROXIMAL TO THE CUT WAS NOT RETURNED FOR EVALUATION. DISTAL TIP DEFORMATION AND DEFORMATION/PUNCTURE DAMAGE TO THE SHAFT PROXIMAL OF THE TRANSDUCER WAS OBSERVED AND IS CONSISTENT WITH THE REPORT THAT THE DR. SNARED THE DEVICE FROM THE DISTAL SIDE. THE PLATINUM PLUS GUIDEWIRE WAS RETURNED WITH THE DEVICE AND THE MEASURED DIAMETER WAS NOMINALLY .018" WHICH IS COMPATIBLE WITH THE PV .018 DEVICE. THERE IS NO EVIDENCE FOUND TO SUGGEST THE CATHETER WAS NOT MANUFACTURED TO SPECIFICATION. NO EVIDENCE WAS FOUND TO INDICATE WHY THE CATHETER WOULD KINK. THIS EVENT IS BEING REPORTED BECAUSE INTERVENTION WAS REQUIRED TO FREE THE PV .018 FROM THE PATIENT. THE PATIENT WAS KEPT OVERNIGHT FOR ADDITIONAL OBSERVATION. FOLLOW-UP INDICATED THE PATIENT IS CURRENTLY DOING FINE.

    Description of Event or Problem · 1

    DURING A RENAL ANGIOGRAM, DR PLACED A 6F, 11CM CORDIS AVANTI + SHEATH IN THE GROIN WITH A 260CM PLATINUM PLUS GUIDEWIRE, AND A VISION PV.018 INTRAVASCULAR ULTRASOUND OVER THAT. THE PV .018 CATHETER BECAME LOOPED UPON ITSELF IN THE ILIAC ARTERY, AND WAS UNABLE TO BE MOVED FORWARD OR BACKWARDS. THE PLATINUM PLUS WIRE WAS REMOVED, BUT THE PV .018 CATHETER WAS UNABLE TO BE REMOVED. SEVERAL ATTEMPTS WERE MADE WITH LARGER SHEATHS AND VARIOUS WIRES UNTIL FINALLY, THE PV .018 WAS CUT INTO TWO DISTAL TO THE LUER AND A SNARE WAS USED (FROM THE CONTRA LATERAL FEMORAL ARTERY) TO ENABLE THE CATHETER TO BE REMOVED FROM THE PATIENT. THIS PROCESS TOOK APPROXIMATELY 45 MINUTES TO AN HOUR. THE PATIENT'S CURRENT STATUS WAS STABLE AND SHE WAS BEING WATCHED FOR ANY HEMATOMAS OR BLEEDING FROM EITHER GROIN SITE. NONE WAS NOTED. THE PATIENT'S HOSPITAL STAY WAS EXTENDED TO OVERNIGHT AND WAS RELEASED THE FOLLOWING DAY. THERE WAS NO DAMAGE TO THE VASCULATURE AS A RESULT OF THE EVENT. THE PATIENT IS CURRENTLY DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIONS PV .018 INTRAVASCULAR ULTRASOUND CATHETER IYO VOLCANO CORPORATION 86700 003 02458

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R