BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DLP PERICARDIAL/INTRACARDIAC SUMPS

    MDR report key: 4346786 · Received December 19, 2014

    Report

    Report Number
    2184009-2014-00097
    Event Type
    Injury
    Date Received
    December 19, 2014
    Date of Event
    November 21, 2014
    Report Date
    November 21, 2014
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DTS
    PMA / PMN Number
    K850385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED TO MEDTRONIC FOR EVALUATION. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION INDICATING THAT DURING THE USE OF THIS CANNULA, THE CANNULA PERFORATED THE BACK OF THE PATIENT¿S HEART. A SECOND PUMP RUN WAS REQUIRED TO RESOLVE THE EVENT. THE SURGEON WAS USING THIS CANNULA AS A SUBSTITUTE DUE TO THE UNAVAILABILITY OF THE SURGEON¿S NORMAL CANNULA. THE SURGEON STATED THAT THIS CANNULA WAS MORE RIGID, WHICH RESULTED IN THE PERFORATION. THE CANNULA WAS DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836412 DLP PERICARDIAL/INTRACARDIAC SUMPS SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS DTS MEDTRONIC PERFUSION SYSTEMS 12112 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Life Threatening| R