BEUDAMED
    FDA Adverse Event Death Summary report: N

    EMPOWER CTA CONNECTING TUBE

    MDR report key: 12511741 · Received September 22, 2021

    Report

    Report Number
    1038185-2021-00001
    Event Type
    Death
    Date Received
    September 22, 2021
    Date of Event
    July 11, 2021
    Report Date
    September 21, 2021
    Manufacturer
    COEUR, INC.
    Product Code
    DXT
    UDI-DI
    M297620426
    PMA / PMN Number
    K150902
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CT SCANS WERE RETURNED TO COUER'S CUSTOMER (ACIST MEDICAL SYSTEMS) FOR EVALUATION BY THE ACIST MEDICAL ADVISORY BOARD (MAB). UPON THE MAB'S COMPLETED REVIEW, THE FOLLOWING ASSESSMENT WAS PROVIDED: "CT SCANS OF THE HEAD WERE REVIEWED, AND NO AIR WAS VISIBLE. BASED ON THE PATIENT'S STATUS (ACUTE STROKE) AND THE ABSENCE OF AIR IDENTIFIED ON THE PATIENT'S CT SCANS, THERE IS INSUFFICIENT EVIDENCE TO INDICATE IV AIR ADMINISTRATION OCCURRED AND THUS NO CAUSAL RELATIONSHIP ESTABLISHED BETWEEN THE EMPOWERCTA INJECTION SYSTEM AND THE REPORTED PATIENT DEATH." THE EMPOWER CTA(R) CONNECTING TUBE WAS INCLUDED AND USED WITH THE EMPOWER CTA INJECTION SYSTEM. AFTER REVIEW OF THE AVAILABLE INFORMATION INCLUDING THE DHR OF THE CTA(R) CONNECTING TUBE AND THE ACIST MAB REVIEW, COUER CONCLUDES THERE IS NO CAUSAL RELATIONSHIP BETWEEN THE EMPOWER CTA(R) CONNECTING TUBE AND THE REPORTED PATIENT DEATH.

    Additional Manufacturer Narrative · 1

    THE COEUR, INC. INSTRUCTIONS FOR USE REQUIRE THE USER TO: "ALWAYS VISUALLY INSPECT THE FLUID DELIVERY SYSTEM PRIOR TO USE" AND TO "EXPEL EXCESS AIR FROM EXTENSION LINE(S) AND ALL CONNECTIONS IN THE FLUID DELIVERY SYSTEM PRIOR TO PERFORMING ANY PROCEDURES." THE FILING OF THIS REPORT WAS DELAYED DUE TO THE INABILITY TO ACCESS THE FDA'S WEBTRADER SERVICE AND USE OF E-SUBMITTER. THIS HAS BEEN RESOLVED AND THE REPORT IS SUBMITTED FOLLOWING APPROVAL OF THE REQUIRED TEST SUBMISSION.

    Description of Event or Problem · 1

    COEUR, INC. WAS NOTIFIED BY ACIST MEDICAL SYSTEMS VIA E-MAIL FROM A REGULATORY COMPLIANCE SPECIALIST ON 21 JULY 2021 THAT AN EVENT OCCURRED ON (B)(6) 2021. THE DESCRIPTION OF THE EVENT PROVIDED BY ACIST STATED THAT A PATIENT WAS ADMITTED INTO (B)(6) BY AN EMERGENCY PHYSICIAN ON SUSPICION OF CEREBRAL INFARCTION. FOLLOWING A COMPUTED TOMOGRAPHY (CT) SCAN WITH AN EMPOWERCTA INJECTION SYSTEM, WHICH USED BOTH THE EMPOWERCT FASTLOAD SYRINGE, LOT # 1866032008 AND EMPOWERCTA CONNECTING TUBE, LOT IAQVJ-1903 AS CONSUMABLES), THE PATIENT WENT INTO CARDIAC ARREST 20 MINUTES AFTER THE PROCEDURE. THE USER FACILITY CONSIDERED THAT AIR MAY HAVE BEEN INJECTED INTO THE PATIENT, BUT THIS WAS NOT CONCLUSIVE. IT WAS REPORTED THE PATIENT IS DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1413623 EMPOWER CTA CONNECTING TUBE ACCESSORY, ANGIOGRAPHIC INJECTOR AND SYRINGE DXT COEUR, INC. IAQVJ-1903 M297620426

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Death ACIST MEDICAL SYSTEMS EMPOWERCT FASTLOAD SYRINGE.| ACIST MEDICAL SYSTEMS EMPOWERCTA INJECTION SYSTEM.| ACIST MEDICAL SYSTEMS EMPOWERCT FASTLOAD SYRINGE| ACIST MEDICAL SYSTEMS EMPOWERCTA INJECTION SYSTEM