BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOCLAMP AORTIC CATHETER

    MDR report key: 2061144 · Received April 18, 2011

    Report

    Report Number
    3008500478-2011-00083
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXC
    PMA / PMN Number
    K962858
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SURGERY; CHANGE IN OPERATIVE STRATEGY. DEVICE WAS NOT RETURNED TO MANUFACTURER. DEVICE WAS RETAINED BY CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR LOT 744130 AND THIS DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. AS THE PRODUCT WAS NOT RETURNED, ROOT CAUSE COULD NOT BE DETERMINED FOR THIS DEVICE THEREFORE A CAPA WAS NOT INITIATED FOR THIS EVENT. THE INFORMATION WILL BE INCLUDED IN TRENDING AND FUTURE CAPA DETERMINATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON KEPT MIGRATING TO THE DISTAL ARCH WHEN PUT THROUGH THE CANNULA TIP. UNABLE TO BE USED FOR CASE. THE DEVICE HAD TO BE SWITCHED OUT DURING USE. PATIENT IMPACT: PROLONGED OR TIME AND HIGH LINE PRESSURES WHEN TRYING TO GET THE BALLOON THROUGH THE CANNULA AND GOING IN THE RIGHT DIRECTION. VISUALIZED ON ECHO THAT IT WAS HEADING DOWN THE DESCENDING AORTA. SALES REP WAS IN CASE. DR. (B)(6) WAS SURGEON. IT WAS TO BE A ROBOTIC MVR/TVR WITH ENDODIRECT APPROACH. HE ENDED ABORTING THE ENDODIRECT PROCEDURE AND INSTEAD ULTIMATELY USED A CHITWOOD CROSSCLAMP. THE BALLOON, WHEN PUT THROUGH THE ED24, KEPT GOING TOWARD THE DISTAL ARCH INSTEAD OF THE AORTIC VALVE MAKING IT UNABLE TO OCCLUDE THE AORTA. HE TRIED TWO BALLOONS-BOTH EC65. PRODUCT WILL NOT BE RETURNED BECAUSE THE PHYSICIAN (B)(6) DECIDED TO KEEP IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOCLAMP AORTIC CATHETER AORTIC CATHETER DXC EDWARDS LIFESCIENCES EC65 744130

    Patients

    Seq Age Sex Outcome Treatment
    1