BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

    MDR report key: 3911620 · Received June 27, 2014

    Report

    Report Number
    1820334-2014-00291
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 11, 2014
    Manufacturer
    COOK, INC.
    Product Code
    DQY
    PMA / PMN Number
    K073378
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    INITIAL INFORMATION RECEIVED STATES: ANTEGRADE LEFT CFA PUNCTURE. DIFFICULT PUNCTURE AND AN AMPLATZ WIRE WAS USED TO NEGOTIATE THE 5FR SHEATH INTO THE COMMON FEMORAL. THE VESSEL WAS EXTREMELY CALCIFIED. A V18 WAS POSITIONED IN THE POPLITEAL AND AN INITIAL ANGIOGRAM SHOWED MULTIPLE STENOSES IN THE SFA. THE DISTAL POPLITEAL WAS RELATIVELY NORMAL AND THERE WAS DISEASED TRIFURCATION WITH A VERY DISEASED ANTERIOR TIBIAL AND AN INITIAL OCCLUSION OF THE PROXIMAL PERONEAL. EXTENSIVE COLLATERALS REFILLED THE PROXIMAL PERONEAL AND THE ANTERIOR TIBIAL WITH THE PERONEAL BEING THE PREDOMINANT RUN OFF VESSEL. THIS CONTINUES DOWN TO THE ANKLE WHERE COLLATERALS RE-FILL A VERY GOOD DORSALIS PEDIS. ADDITIONAL INFORMATION INDICATED THAT: A 5 MM X 4 CM BALLOON ANGIOPLASTY WAS PERFORMED IN THE PROXIMAL SFA. HOWEVER, A SECOND INFLATION OF THE BALLOON THE BALLOON BURST. THE BALLOON WAS SUBSEQUENTLY REMOVED, HOWEVER THE BALLOON ITSELF WAS SHEARD FROM THE SHAFT OF THE DELIVERY DEVICE. THE BALLOON REMAINED WITHIN THE SHEATH INITIALLY. DESPITE ATTEMPTS AT RETRIEVAL THEY WERE UNABLE TO GET ACCESS AND SNARE THIS BALLOON. THE BALLOON WAS SUBSEQUENTLY LEFT IN SITU WITH A WIRE IN POSITION AND THE CASE DISCUSSED WITH THE VASCULAR SURGEON. UNFORTUNATELY THEY WERE UNABLE TO REPOSITION A 5FR SHEATH IN THE GROIN AND AS SUCH THE WIRE AND THE DILATOR WAS REMOVED. THIS LEFT THE BALLOON IN SITU IN THE PROXIMAL SFA. ON THE LAST FILM THIS BALLOON APPEARS TO HAVE COMPRESSED SUCH THAT THE TWO BALLOON MARKERS WERE NOW VERY CLOSE TOGETHER. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR SURGICAL REMOVAL OF THE DISTAL SEGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376290 ADVANCE 18 LP LOW PROFILE BALLOON CATHETER DQY CATHETER, PERCUTANEOUS DQY COOK, INC. NA 4847244

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention