BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WILDCAT GUIDEWIRE SUPPORT CATHETER

    MDR report key: 3370218 · Received September 18, 2013

    Report

    Report Number
    3007498664-2013-00006
    Event Type
    Injury
    Date Received
    September 18, 2013
    Date of Event
    June 24, 2013
    Report Date
    September 16, 2013
    Manufacturer
    AVINGER INC.
    Product Code
    DQY
    PMA / PMN Number
    K111338
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THE EVENT, THERE WAS NO INDICATION THAT THE WILDCAT DEVICE CAUSED OR CONTRIBUTED TO THE PT'S INJURY. AVINGER QUALITY ASSURANCE (QA) BECAME AWARE OF THE (B)(6) 2013 EVENT ON 08/21/2013 DURING PERIODIC REVIEW OF THE MAUDE DATABASE WHERE A CSI MDR ALLEGED AN INCIDENT RESULTING IN PT INJURY INVOLVING A WILDCAT CATHETER (MDR #3004742232-2013-00020). AVINGER QA FOLLOWED-UP WITH CARDIOVASCULAR SYSTEMS INC (ORIGINAL EVENT REPORTER), ARROWHEAD HOSPITAL, AND THE SALES REP PRESENT DURING THE PROCEDURE TO OBTAIN FURTHER INFORMATION. METHOD: THE CASE INFORMATION, INCLUDING FEEDBACK OBTAINED FROM THE EVENT REPORTER, WAS USED TO EVALUATE THE REPORTED EVENT. RESULTS: PERFORATION IS DEFINED IN THE LABELING (INSTRUCTIONS FOR USE) AS A POSSIBLE COMPLICATION. IN THIS EVENT, USE OF THE ORBITAL ATHERECTOMY DEVICE AFTER THE WILDCAT MAY HAVE CONTRIBUTED TO THE SEVERITY OF THE PERFORATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PT PRESENTED FOR REVASCULARIZATION OF A MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). USING A GLIDEWIRE AND WILDCAT DEVICE, THE 100% OCCLUSION WAS CROSSED. AT THIS TIME DURING THE CASE, THERE WAS STILL NO FLOW THROUGH THE LESION AND THUS NO INDICATION ON ANGIO THAT THE VESSEL WAS DAMAGED. HOWEVER, IN THE POST OPERATIVE REPORT THE PHYSICIAN STATED THAT THEY PROBABLY WENT INTO A DISSECTION PLANE IN THE MIDPORTION OF THE SFA. SUBSEQUENTLY, THE PHYSICIAN PROCEEDED WITH THE CARDIOVASCULAR SYSTEMS INC ORBITAL ATHERECTOMY SYSTEM AND MADE MULTIPLE RUNS WITH THE DEVICE BEFORE ANGIOPLASTY WAS PERFORMED. MULTIPLE BALLOONS WERE INFLATED TO PRESSURES RANGING FROM 6-10 ATMOSPHERES FOR VARIOUS DURATIONS. POST DILATION, THE ANGIOGRAM SHOWED THAT THE PERFORATION MID SUPERFICIAL FEMORAL ARTERY HAD NOT RESOLVED. A VIABAHN ENDOPROSTHESIS WAS DEPLOYED WITH 100% RESOLUTION OF THE EXTRAVASATION AND VESSEL NARROWING WAS REDUCED TO 0%. NO FURTHER PT COMPLICATIONS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469671 WILDCAT GUIDEWIRE SUPPORT CATHETER PERCUTANEOUS CATHETER DQY AVINGER INC. W400 130308A

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention GLIDEWIRE| STEALTH 360 ORBITAL ATHERECTOMY SYSTEM| FLEXOR ANSEL SHEATH| VIPERWIRE