BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROPLEGIA/CARDIOPLEGIA CANNULA

    MDR report key: 2440921 · Received February 7, 2012

    Report

    Report Number
    3008500478-2012-00198
    Event Type
    Injury
    Date Received
    February 7, 2012
    Date of Event
    January 19, 2012
    Report Date
    March 12, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    K880103
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: ONE RETROGRADE CANNULA WAS RECEIVED INSIDE A PLASTIC BAG. THE CANNULA WAS EVALUATED BY QUALITY AND MANUFACTURING ENGINEERING AT EDWARDS. THE CANNULA WAS NOT RECEIVED IN ITS ORIGINAL PACKAGING. THE REPORTED COMPLAINT OF BALLOON RUPTURE WAS CONFIRMED. THE BALLOON ON THE RETROGRADE CANNULA, (B)(4) DEVICE, HAD A LARGE HOLE WHERE A PIECE OF THE BALLOON HAD SEPARATED. THE PIECE MISSING FROM THE BALLOON WAS RECEIVED WITH THE DEVICE. ALL LUMENS ON THE DEVICE WERE CLEAR OF OBSTRUCTION/OCCLUSION AND PASSED PATENCY TESTS. ALL HOLES ON THE RETURNED DEVICE WERE CORRECTLY PLACED AND FREE OF OBSTRUCTION. THE BALLOON WALL THICKNESS MEASURED 0.007 INCHES WHICH MEETS THE DOUBLE WALL THICKNESS SPECIFICATION. NO OTHER ISSUES WERE IDENTIFIED DURING THE EVALUATION OF THE RETURNED DEVICE. A DEVICE HISTORY REVIEW WAS PERFORMED AND THERE WERE NO NONCONFORMITIES ASSOCIATED WITH THE MANUFACTURING OF THIS LOT. THE COMPLAINT DESCRIPTION STATES THAT THE FLOW WAS AT 350ML/MIN. PER THE INSTRUCTIONS FOR USE: IT STATES DO NOT EXCEED FLOW OF 120 ML/MIN TO AVOID POSSIBLE OVER INFLATION AND CORONARY SINUS INJURY. THE ISSUE MOST LIKELY RESULTED FROM THE EXCESSIVE FLOW RATE DURING THE PROCEDURE. DURING THE MANUFACTURING PROCESS, EACH BALLOON IS INSPECTED FOR DEFECTS AND WALL THICKNESS, AND IS ALSO AIR TESTED AT 3 PSI; THEREFORE, IT IS UNLIKELY THAT THE REPORTED ISSUE RESULTED FROM A MANUFACTURING NON-CONFORMANCE. A CAPA WILL NOT BE INITIATED FOR THIS EVENT. THE INFORMATION WILL BE INCLUDED IN TRENDING AND FUTURE CAPA DETERMINATIONS. INASMUCH AS A MANUFACTURING DEFECT CANNOT BE CONFIRMED. TRENDS WILL CONTINUE TO BE MONITORED ON A MONTHLY BASIS AND IF FURTHER ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 1

    PATIENT EXPERIENCED A TEAR IN HER CORONARY SINUS. H3:PRODUCT EVALUATION IS ANTICIPATED UPON THE RETURN OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT WAS IN SURGERY FOR AVR AND A CABG PROCEDURE. IT WAS REPORTED THAT THE BALLOON ON THE RETROPLEGIA CATHETER RUPTURED DURING THE SECOND ATTEMPTED INSERTION INTO THE CORONARY SINUS. THIS RESULTED IN A RIPPING OF THE CORONARY SINUS. THE PATIENT NEEDED TO UNDERGO FURTHER SURGERY TO FIX THE TEAR. DURING THE SURGERY, THE LINE WAS PRESSURIZED AT 450MMHG. THE FLOW WAS AT 350ML/MIN. THE CORONARY SINUS PRESSURE WAS BETWEEN 25 TO 35MMHG. THE CORONARY SINUS WAS TORN FOR 4CM, BUT IT WAS REPAIRED WITHOUT ANY ADDITIONAL COMPLICATIONS. THE CUSTOMER DID STATE THAT THE EVENT WAS LIKELY DUE TO THE PATIENT'S UNDERLYING DISEASE PROCESSES OF AORTIC STENOSIS AND ANGINA PECTORIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETROPLEGIA/CARDIOPLEGIA CANNULA CARDIOPLEGIA CANNULA DWF EDWARDS LIFESCIENCES RC2012 59060847

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R