BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PITON Y-ADAPTER, SUB ASSY

    MDR report key: 1024220 · Received March 27, 2008

    Report

    Report Number
    1220452-2008-00018
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 21, 2008
    Manufacturer
    MEDTRONIC INC.
    Product Code
    DTL
    PMA / PMN Number
    K945461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE SUBJECT DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. THEREFORE, AN ENGINEERING ANALYSIS OF THE SUBJECT DEVICE CAN NOT BE PERFORMED. THE LOT NUMBER OF THE DEVICE WAS UNKNOWN AND THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD CAN NOT BE PERFORMED. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE OF THE ACTUAL COMPLAINT SAMPLE IS RETURNED A FOLLOW-UP MEDWATCH WILL BE SUBMITTED. AT THIS TIME THIS IS CONSIDERED TO BE THE INITIAL AND FOLLOW-UP MEDWATCH BEING SUBMITTED. DEVICE DISCARDED- NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO US THAT DURING THE PROCEDURE AIR WAS INJECTED INTO THE PATIENT RIGHT CORONARY ARTERY. THE PHYSICIAN WAS USING THE TOUHY BORST ADAPTER FOR THE PROCEDURE. AT SOME POINT DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO CLOSE THE CAP OF THE ADAPTER, BUT HAD DIFFICULTY CLOSING IT TIGHTLY. THE PHYSICIAN THOUGHT THE ADAPTER WAS CLOSED AND CONTINUED THE PROCEDURE AND AT SOME POINT, AIR BECAME INJECTED INTO THE PATIENT'S RIGHT CORONARY ARTERY RESULTING IN AN AIR EMBOLISM. THE PATIENT HAD ST ELEVATION. THE PATIENT WAS TREATED SUCCESSFULLY AND IS REPORTED TO BE FINE. THE ACTUAL DEVICE USED DURING THE CASE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PITON Y-ADAPTER, SUB ASSY DTL MEDTRONIC INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA