BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTERJECT

    MDR report key: 17076034 · Received June 6, 2023

    Report

    Report Number
    3005099803-2023-02876
    Event Type
    Death
    Date Received
    June 6, 2023
    Date of Event
    May 12, 2023
    Report Date
    June 6, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCG
    UDI-DI
    08714729296430
    PMA / PMN Number
    K171454
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT NEEDLE WAS USED IN THE ESOPHAGUS DURING A PERORAL ENDOSCOPIC MYOTOMY (POEM) PROCEDURE PERFORMED ON (B)(6) 2023, FOR THE TREATMENT OF ACHALASIA. DURING THE PROCEDURE, THE PATIENT BEGAN TO PRESENT LOW VITALS INCLUDING LOW BLOOD PRESSURE AND DECREASED PULSE. IT WAS REPORTED THAT THEY PERFORMED CPR FOR AROUND 20 MINUTES AND THE PATIENT WAS TRANSFERRED FROM THE OPERATING ROOM TO THE INTENSIVE CARE UNIT WHERE AT SOME POINT THEY PASSED AWAY. THE PHYSICIANS PRESENT WERE ABLE TO CONFIRM THAT DUE TO ANESTHESIA ERROR, THE PATIENT DID NOT HAVE ACCESS TO ANESTHESIA MACHINE VENTILATION, AS THE VENTILATION TUBE WAS BENT. IN THE PHYSICIAN'S ASSESSMENT, THE INTERJECT NEEDLE DEVICE WAS USED CORRECTLY AND DID NOT CONTRIBUTE TO THE PATIENT'S DEATH. IT WAS CONFIRMED THAT ANESTHESIOLOGY ERROR WAS THE CAUSE OF DEATH. THERE WAS NO ALLEGED MALFUNCTION OF THE INTERJECT NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093583 INTERJECT BIOPSY NEEDLE FCG BOSTON SCIENTIFIC CORPORATION M00518151 0028241475 08714729296430

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| D| O