BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRACEPT ACCESS INSTRUMENTS - TROCAR

    MDR report key: 8102634 · Received November 26, 2018

    Report

    Report Number
    3006789852-2018-00002
    Event Type
    Injury
    Date Received
    November 26, 2018
    Date of Event
    November 2, 2018
    Report Date
    November 26, 2018
    Manufacturer
    RELIEVANT MEDSYSTEMS INC
    Product Code
    GXI
    UDI-DI
    00852454006028
    PMA / PMN Number
    K170827
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN HAD SUCCESSFULLY COMPLETED CADAVER TRAINING AND WAS WELL VERSED IN TRANS-PEDICULAR ACCESS, HAVING PERFORMED MANY KYPHOPLASTY PROCEDURES AND INSTRUMENTED FUSION SURGERIES. DURING THE CASE, THE PHYSICIAN APPROACHED THE LEFT L5 PEDICLE WITH THE INTRACEPT INTRODUCER USING AN OBLIQUE EN FACE VIEW UNDER C-ARM FLUOROSCOPIC GUIDANCE. A LATERAL FLUOROSCOPIC IMAGE ESTABLISHED THAT THE TIP OF THE INTRODUCER WAS VENTRAL TO THE SPINOUS PROCESS, AND THE SURGEON REMOVED THE INTRODUCER. HE RE-INITIATED THE PROCEDURE USING A 22-GAUGE SPINAL NEEDLE AS A GUIDE. THE REMAINDER OF THE PROCEDURE WENT WITHOUT INCIDENT, AND THE BASIVERTEBRAL NERVES WERE SUCCESSFULLY ABLATED ON THE LEFT AT L5 AND THE RIGHT AT L4. THERE WERE NO INTRA-OPERATIVE OR IMMEDIATE POST-OPERATIVE SIGNS OR SYMPTOMS OF COMPLICATION NOTED. THE SURGEON CONTACTED THE TERRITORY MANAGER STATING THAT THE PATIENT WAS TAKEN TO THE HOSPITAL WITH A RETROPERITONEAL HEMATOMA. PT WAS TRANSFERRED 4 1/2 HRS POST OP WITH HYPOTENSION TO LOCAL TRAUMA HOSPITAL. GOT 5 UNITS. ANGIO WAS NEGATIVE AND GOT SOME "ILIOLUMBARS" COILS TO BE SAFE. WENT HOME (B)(6) 2018. ONLY PAIN SHE HAD ON THAT DAY WAS BY THE LLQ WHERE THE HEMATOMA WAS. NO REPORTED BACK PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941586 INTRACEPT ACCESS INSTRUMENTS - TROCAR TROCAR INTRODUCER GXI RELIEVANT MEDSYSTEMS INC FG0045 127331317A 00852454006028

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention INTRACEPT FLEXIBLE BI-POLAR RF PROBE