BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-MEDICUS NG 17 FR ARTERIAL CANNULA

    MDR report key: 7983265 · Received October 19, 2018

    Report

    Report Number
    2184009-2018-00030
    Event Type
    Injury
    Date Received
    October 19, 2018
    Date of Event
    June 19, 2018
    Report Date
    October 19, 2018
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DWF
    PMA / PMN Number
    K924642
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WITH THE INFORMATION AVAILABLE AT THIS TIME, MEDTRONIC IS UNABLE TO DETERMINE A RELATIONSHIP BETWEEN THE CANNULA AND THE ADVERSE PATIENT OUTCOMES DESCRIBED IN THE LITERATURE. CITATION: YANG ET AL. ANN. INTENSIVE CARE (2018) 8:72 HTTPS://DOI.ORG/10.1186/S13613-018-0417-3. DATE OF PUBLISH USED FOR INCIDENT DATE. CANNULA MODEL 96570-015 ENTERED AS A PLACEHOLDER AS SPECIFIC MODEL AND LOT NUMBERS WERE NOT PROVIDED NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED. MEAN PATIENT AGE OF STUDY POPULATION USED FOR PATIENT AGE. MAJORITY GENDER OF STUDY POPULATION USED FOR PATIENT GENDER. 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 THE VASCULAR COMPLICATION IN ADULT POST CARDIOTOMY CARDIOGENIC SHOCK PATIENTS RECEIVING VENOARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA-ECMO). ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN JANUARY 2004 AND DECEMBER 2015. THE STUDY POPULATION INCLUDED 72 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 52 YEARS) WHO HAD MAJOR VASCULAR COMPLICATION (MVC) AFTER BEEN TREATED WITH (VA-ECMO). THE VA-ECMO SYSTEM CONTAINED CANNULAE FROM MEDTRONIC (MODEL AND LOT NUMBERS NOT PROVIDED). AMONG ALL PATIENTS 12 DEATHS OCCURRED DUE TO UNKNOWN CAUSES. BASED ON THE AVAILABLE INFORMATION, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: SEVERE LIMB ISCHEMIA WHO PROGRESSED TO COMPARTMENT SYNDROME REQUIRING PROPHYLACTIC FASCIOTOMY, REQUIRED LIMB AMPUTATION, PATIENTS WITH BLEEDING OR HEMATOMA AT THE CANNULATION SITE REQUIRING SURGICAL EXPLORATION, FEMORAL ARTERY EMBOLISM REQUIREMENT SURGICAL INTERVENTION, RETROPERITONEAL BLEEDING. BASED ON THE AVAILABLE INFORMATION, A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND MEDTRONIC PRODUCT. AMONG ALL PATIENTS THERE WERE NO DEVICE MALFUNCTIONS NOTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827895 BIO-MEDICUS NG 17 FR ARTERIAL CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF PERFUSION SYSTEMS 96570-117 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization