BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRACLUDE INTRA-AORTIC OCCLUSION CATHETER

    MDR report key: 9690055 · Received February 10, 2020

    Report

    Report Number
    3008500478-2020-00187
    Event Type
    Injury
    Date Received
    February 10, 2020
    Date of Event
    January 14, 2020
    Report Date
    January 14, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXC
    PMA / PMN Number
    K163693
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: UDI NUMBER: (B)(4). THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND SHOWS THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASE PRIOR TO DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. THERE IS PROOF OF THIS MANDATORY RECALL WAS ACKNOWLEDGED BY THE FACILITY. REPORTEDLY, THE SURGEON WAS AWARE OF THE RECALL, AND THE PATIENT WAS AWARE OF THE RECALL PRIOR TO ITS PLANNED INTRAOPERATIVE USE; AN INFORMED CONSENT WAS OBTAINED. THE FEMORAL DISSECTION WAS ATTRIBUTED TO THE USE OF A NON-EDWARDS FEMORAL SHEATH, WITHOUT A DEVICE MALFUNCTION OF THE ICF-100. IN THE CURRENT RECALL, FEMORAL DISSECTIONS WERE NOT A CONDITION OF AN ICF-100 MALFUNCTION. THE USE OF THE ICF-100 HOLDS POTENTIAL FOR A MALFUNCTION THAT COULD RESULT IN OTHER SERIOUS INJURIES OR DEATH, ALTHOUGH IN THIS CASE, NO MALFUNCTION WAS ALLEGED/DETECTED. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT UPON INFLATION OF AN INTRA-AORTIC OCCLUSION DEVICE, THE SURGEON NOTED A FEMORAL RETROGRADE DISSECTION AND THE BALLOON WAS IMMEDIATELY DEFLATED AND CARDIOPULMONARY BYPASS WAS DISCONTINUED. THE (B)(6) FEMALE PATIENT WAS SCHEDULED FOR ROBOTIC MITRAL VALVE REPAIR AND MAZE PROCEDURE (REDO CHEST FROM PREVIOUS ASD CLOSURE). EDWARDS LATER LEARNED THAT A NON-EDWARDS FEMORAL SHEATH WAS USED IN CONJUNCTION WITH THE INTRA-AORTIC OCCLUSION DEVICE. THE SURGEON CONFIRMED THAT THE INTRA-AORTIC OCCLUSION DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE FEMORAL DISSECTION. AS REPORTED, ON POD #1, THE PATIENT WAS EXTUBATED AND DOING WELL. SURGEON REPORTED THE DISSECTION WAS NOT CAUSED BY THE INTRA-AORTIC OCCLUSION DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149146 INTRACLUDE INTRA-AORTIC OCCLUSION CATHETER CLAMP, VASCULAR DXC EDWARDS LIFESCIENCES ICF100 62087517

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other