BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTO INFLATE RCSP

    MDR report key: 7167418 · Received January 5, 2018

    Report

    Report Number
    2184009-2018-00001
    Event Type
    Injury
    Date Received
    January 5, 2018
    Date of Event
    January 30, 2015
    Report Date
    January 5, 2018
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DWF
    PMA / PMN Number
    K123762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: HIROYUKI TSUKUI. LEFT ATRIAL DISSECTION RELATED TO RETROGRADE CARDIOPLEGIA CANNULA INSERTION. HEART VESSELS. 2016 MAY;31(5):819-21. DOI: 10.1007/S00380-015-0634-8. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. THE MODEL AND CATALOG NUMBER WERE ARBITRARILY CHOSEN, AS NO UNIQUE DEVICE IDENTIFIER (MODEL/LOT) NUMBERS WERE PROVIDED. THE 510K NUMBER WAS POPULATED USING THIS ARBITRARY NUMBER. WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING LEFT ATRIAL DISSECTION (LAD) RELATED TO RETROGRADE CARDIOPLEGIA CANNULA INSERTION. THIS WAS A CASE STUDY ON A (B)(6) YEAR OLD MALE PATIENT, WHO UNDERWENT CARDIOPULMONARY BYPASS USING A MEDTRONIC DLP CANNULA WITH AUTO INFLATE CUFF FOR RETROGRADE CARDIOPLEGIA. THE CANNULA WAS INSERTED INTO THE CORONARY SINUS (CS) WITH DIRECT VISION AND NO ISSUES WERE OBSERVED DURING INSERTION. WHILE WEANING FROM BYPASS, A BULGE ON THE POSTERIOR WALL OF THE LEFT ATRIUM WAS NOTED CAUSING COMPROMISED BLOOD FLOW, AND AT THIS POINT A LAD WAS DIAGNOSED. THE CUSTOMER SUGGESTED THE TIP OF THE CANNULA MAY HAVE PERFORATED THE CS DUE TO THE EXCESSIVE TRACTION ON THE HEART TO EXPOSE THE MITRAL VALVE DURING SURGERY, AND THE INFUSION OF CARDIOPLEGIA SOLUTION ULTIMATELY CAUSED THE LAD. THE LAD WAS DRAINED, BLOOD FLOW RETURNED TO NORMAL, AND THE PATIENT WAS WEANED FROM BYPASS AND DISCHARGED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11252 AUTO INFLATE RCSP CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF PERFUSION SYSTEMS 94315T UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention