BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EOPA ARTERIAL CANNULA

    MDR report key: 6195568 · Received December 21, 2016

    Report

    Report Number
    2184009-2016-00048
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    May 17, 2011
    Report Date
    November 24, 2016
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DWF
    PMA / PMN Number
    K031037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. THE RETURN OF THE PRODUCT, FACILITY, INITIAL REPORTER, PATIENT IMPACT AND DEMOGRAPHICS WERE REQUESTED BUT COULD NOT BE PROVIDED BY (B)(6). SHOULD THE PRODUCT BE RETURNED, ADDITIONAL INFORMATION RECEIVED, OR IF THE COMPLETED INVESTIGATION YIELDS NEW INFORMATION, A FOLLOW UP REPORT WILL BE SUBMITTED. NO UNIQUE DEVICE IDENTIFIERS (MODEL OR LOT NUMBERS) WERE PROVIDED. THE MODEL AND CATALOG NUMBERS WERE CHOSEN ARBITRARILY BASED ON THE PRODUCT DESCRIPTION IN THE REPORT. THE 510K NUMBER WAS CHOSEN BASED ON THIS SELECTED MODEL NUMBER.

    Additional Manufacturer Narrative · 1

    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.

    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 NOTIFICATION FROM THE THERAPEUTIC GOODS ADMINISTRATION A DEVICE INCIDENT REPORT WAS RECEIVED INDICATING THAT DURING A CASE, THE SUTURE COLLAR FROM THIS ARTERIAL CANNULA FELL OFF THE CANNULA INTO THE PATIENT'S AORTA. THE OPERATION WAS COMPLETED. THE PATIENT WAS TAKEN TO RADIOLOGY, USING X-RAY THE SUTURE COLLAR WAS LOCATED IN THE FEMORAL ARTERY. A SECOND SURGERY WAS PERFORMED THE SAME DAY AND THE SUTURE COLLAR WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842411 EOPA ARTERIAL CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MEDTRONIC PERFUSION SYSTEMS 77420 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention