BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE APICAL CORING KNIFE

    MDR report key: 9716588 · Received February 17, 2020

    Report

    Report Number
    2916596-2020-00793
    Event Type
    Injury
    Date Received
    February 17, 2020
    Date of Event
    January 29, 2020
    Report Date
    April 16, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010227
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B5, D4 (EXPIRATION DATE), H4: ADDITIONAL INFORMATION. SECTION D4: CORRECTION TO SERIAL AND LOT NUMBER. UDI WAS CORRECTED. SECTION D6: DATE OF IMPLANT WAS ADDED TO THE PREVIOUS REPORT INCORRECTLY. DATE OF IMPLANT IS NOT APPLICABLE. CORING KNIFE IS NOT AN IMPLANTABLE DEVICE. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORT OF THE APICAL CORING KNIFE, LOT NUMBER 7112502, FALLING INTO THE LEFT VENTRICLE AND MIGRATING TO THE LEFT ATRIUM COULD NOT BE CONFIRMED AS NO IMAGES ARE AVAILABLE FOR INVESTIGATION. A SPECIFIC CAUSE FOR THESE EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. HEARTMATE 3 LVAS IFU SECTION 5 ENTITLED ¿SURGICAL PROCEDURES¿ OUTLINES HOW TO PREPARE THE CORING KNIFE, INCLUDING HOW TO INSERT THE HANDLE TO ENABLE HANDLING OF THE TOOL DURING THE SURGICAL PROCEDURE. SECTION 5 ALSO OUTLINES HOW TO CORE THE VENTRICULAR APEX USING THE CORING KNIFE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THIS EVENT.

    Description of Event or Problem · 0

    IT WAS LATER REPORTED THAT THE X-RAY OF THE CORING TOOL INSIDE THE HEART WAS NOT AVAILABLE FOR REVIEW. THE PATIENT DID NOT PRESENT WITH ANY SYMPTOMS THAT LED TO THE X-RAY BEING TAKEN. THE X-RAY WAS A STANDARD POST OPERATING X-RAY TAKEN BEFORE LEAVING THE OPERATING ROOM. THE PATIENT WAS DOING VERY WELL AND WAS STABLE. THE HEART WAS VERY FULL WHEN CORING SUCH THAT BLOOD WAS SHOOTING OUT OF THE CORE. THE CORING KNIFE FELL IN AT THAT TIME.

    Description of Event or Problem · 0

    PATIENT WENT HOME WITH NO ISSUE.

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER WAS NOT PROVIDED, BUT WILL BE REQUESTED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON X-RAY CORING TOOL WAS FOUND WITHIN PATIENT'S CHEST. MEDIASTINAL INCISION WAS REOPENED AND CORING TOOL WAS FOUND IN THE LEFT ATRIUM (LA). IT APPEARS TO HAVE FALLEN WITHIN THE LEFT VENTRICLE (LV) AND MIGRATED TO THE LA. PATIENT WENT BACK ON BYPASS, CORING TOOL WAS EXCISED FROM LA AND LA WAS REPAIRED. PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181275 HEARTMATE APICAL CORING KNIFE VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 1050 7112502 00813024010227

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention