BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WILDCAT GUIDEWIRE SUPPORT CATHETER

    MDR report key: 2031122 · Received March 22, 2011

    Report

    Report Number
    3007498664-2011-00002
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 22, 2011
    Manufacturer
    AVINGER, INC.
    Product Code
    DQY
    PMA / PMN Number
    K101647
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE CASE INFORMATION AND ANGIOGRAMS WERE USED TO EVALUATE THE DEVICE PERFORMANCE. RESULTS: PERFORATIONS ARE DEFINED IN THE; LABELING (INSTRUCTION FOR USE) AS A POSSIBLE COMPLICATION.

    Description of Event or Problem · 1

    PATIENT WAS BEING TREATED FOR CLAUDICATION. PROCEDURE ENTRY LOCATION WAS THE RIGHT FEMORAL ARTERY. ANGIOGRAM OF RIGHT LEG WITH DISTAL RUN OFF WAS PERFORMED. ANGIOGRAM OF LEFT LEG PERFORMED. REVIEW OF ANGIOGRAMS SHOWS NO CLEAR ORIGIN OF LEFT POSTERIAL TIBIAL MAKING DETERMINATION OF LOCATION OF DEVICE IN ARTERY CHALLENGING. AN ATTEMPT WAS PERFORMED TO CROSS WHAT WAS BELIEVED TO BE THE LEFT POSTERIOR TIBIAL ARTERY WITH SPECTRANETICS SUPPORT CATHETER. THE SUPPORT CATHETER WAS THEN REMOVED AND REPLACED WITH A WILDCAT SUPPORT CATHETER AND ADVANCED. GUIDEWIRE WAS CHANGED TO CONFIANZA PRO 300. THE GUIDEWIRE WAS THEN CHANGED TO CHOICE PT GRAPHIX EX AND CONTINUED TO ATTEMPT TO CROSS THE OCCLUDED LEFT POSTERIOR TIBIAL. WILDCAT SUPPORT CATHETER WAS REMOVED AND SPECTRANETICS SUPPORT CATHETER ADVANCED. WIRE CHANGED TO MEDI ZIPWIRE 0.035" 180 CM STANDARD ANGLED. PERFORATION NOTED IN WHAT WAS ASSUMED TO BE THE ORIGIN OF THE LEFT POSTERIAL TIBIAL. GLIDEWIRE ADVANCED DOWN LEFT PERONEAL AND SUPPORT CATHETER WAS REMOVED. ABBOTT INDEFLATOR 20/30 WAS USED WITH INVATEC BALLOON ADMIRAL 4X120X80. BALLOON WAS PREPPED AND ADVANCED ACROSS THE DISTAL SUPERFICIAL FEMORAL, LEFT, THEN INFLATED TO 10 ATM FOR 0:18 SECONDS. BALLOON REMOVED AND WIRE EXCHANGED FOR GUIDEWIRE STIFF 0.035" 260CM. INVATEC BALLOON ADMIRAL 4X120X130 WAS PREPPED AND ADVANCED ACROSS THE DISTAL POPLITEAL, LEFT, THEN INFLATED TO 7 ATM FOR 3:53 SECONDS. BALLOON REMOVED ANGIOGRAM PERFORMED AND PERFORATION SEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WILDCAT GUIDEWIRE SUPPORT CATHETER PERCUTANEOUS CATHETER DQY AVINGER, INC. W500 101001A

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention SPECTRANETICS CATHETER SUPPORT 0.035X135| STANDARD ANGLED| TERUMO GUIDEWIRE STIFF 0.035" 260CM| BOSTON SCIENTIFIC MEDI ZIPWIRE 0.035" 180CM| WIRE ASAHI CONFIANZA PRO 300| GUIDEWIRE CHOICE PT EX| INVATEC BALLOON ADMIRAL 4X120X130