BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEARVIEW ARTERIOTOMY SHUNT

    MDR report key: 5087323 · Received September 18, 2015

    Report

    Report Number
    2184009-2015-00112
    Event Type
    Injury
    Date Received
    September 18, 2015
    Date of Event
    August 20, 2015
    Report Date
    August 21, 2015
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DWF
    PMA / PMN Number
    K993677
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE DEVICE HAS NOT BEEN RETURNED. MEDTRONIC HAS INITIATED AN INVESTIGATION INTO THE POTENTIAL ROOT CAUSE OF THE EVENT. UPON COMPLETION OF ANALYSIS AND/OR INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (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 AN OFF PUMP CASE, THE SHUNT WAS INSERTED IN THE LUMEN OF THE CORONARY ARTERY AND THE ANASTOMOSIS WAS COMPLETED. AS THE SHUNT WAS REMOVED, ONLY THE DISTAL PORTION WAS REMOVED; THE PROXIMAL PORTION REMAINED IN THE PATIENT'S ARTERY. THE ANASTOMOSIS WAS REOPENED AND THE FRAGMENT WAS EXTRACTED WITH A FORCEPS. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618024 CLEARVIEW ARTERIOTOMY SHUNT CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF PERFUSION SYSTEMS 31100 2014081088

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention