BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALWAYS-ON TIP TRACKED 22GA FLEXIBLE NEEDLE

    MDR report key: 11721779 · Received April 25, 2021

    Report

    Report Number
    3007222345-2021-00009
    Event Type
    Injury
    Date Received
    April 25, 2021
    Date of Event
    April 20, 2021
    Report Date
    August 1, 2023
    Manufacturer
    VERAN MEDICAL TECHNOLOGIES, INC
    Product Code
    JAK
    UDI-DI
    00815686020637
    PMA / PMN Number
    K170023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO CORRECT INFORMATION PROVIDED IN THE INITIAL MEDWATCH REPORT, TO PROVIDE ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT (B5), AND TO PROVIDE INFORMATION THAT WAS INADVERTENTLY NOT PROVIDED IN THE INITIAL MEDWATCH REPORT. CORRECTION TO G3 OF THE INITIAL MEDWATCH REPORT: DATE RECEIVED BY MANUFACTURER WAS 20-APR-2021. THE SUBJECT DEVICE WAS NOT RETURNED, AS THE DEVICE WAS DISPOSED OF BY THE FACILITY. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE VERAN REPRESENTATIVE THAT WAS PRESENT FOR THE REPORTED EVENT ALERTED THE PHYSICIAN THAT HE WAS PAST THE NODULE AND CLOSE TO THE PLEURA WHILE SAMPLING WITH THE NEEDLE. THE VERAN REPRESENTATIVE ADVISED PULLING BACK THE INSTRUMENT TO AVOID THE PLEURA. A PNEUMOTHORAX IS A KNOWN RISK OF THE DEVICE AND THE PROCEDURE. VERAN WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CORRECTIVE ACTION FOLLOWING A RETROSPECTIVE REVIEW OF COMPLAINTS IN RESPONSE TO AN OBSERVATION FROM AN EXTERNAL INSPECTION.

    Description of Event or Problem · 0

    CLARIFICATION REGARDING THE REPORTED EVENT: THE PATIENT DEVELOPED A PNEUMOTHORAX THAT REQUIRED PLACEMENT OF A CHEST TUBE. GRADE WAS 100% PNEUMOTHORAX WITH TENSION.

    Description of Event or Problem · 1

    PATIENT HAD A DIFFICULT GGL IN THE RML. THE NODULE HAD NO DEFINED AIRWAY TO IT. REGISTRATION WAS GOOD AND NO ISSUES. THE DOCTOR WAS ABLE TO NAVIGATE AND GET THERE WITH THE FORCEPS. HE HAD ROSE IN THE ROOM. THEY CONFIRMED ATYPICAL CELLS. DR THEN PROCEEDED TO USE THE 22GA NEEDLE. DR TOOK APPROX. 3 NEEDLE BIOPSIES WHICH RESULTED IN A MALIGNANT CALL FROM ROSE. WHILE USING THE NEEDLE, MANUFACTURER REP WAS IN THE ROOM AND NOTED TO THE DOCTOR THAT HE HAD ADVANCED PAST THE NODULE AND WAS NEAR THE PLEURA AND TO PULL BACK. AFTER THE 22GA HE USED THE TRIPLE NEEDLE BRUSH. HE MADE 1 PASS WITH THE TRIPLE NEEDLE BRUSH. AFTER THAT THE PATIENT STARTED COUGHING AND BUCKING. HE WANTED TO GO BACK AND GET MORE FORCEPS SAMPLES BUT THE AIRWAYS ON OUR TOWER WEREN'T MATCHING THE ACTUAL AIRWAYS OF THE PATIENT. WE WENT TO GO BACK TO RE REGISTER AND HE DECIDED HE HAD ENOUGH SAMPLES AND FINISHED THE CASE. ONCE THE PATIENT WOKE FROM THE ANESTHESIA, DR. NOTICED SOMETHING WAS WRONG. PATIENT WAS BROUGHT IMMEDIATELY BACK INTO THE ROOM AND A CHEST TUBE WAS PLACED. PATIENT RECOVERED AND RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617931 ALWAYS-ON TIP TRACKED 22GA FLEXIBLE NEEDLE FLEXIBLE NEEDLE JAK VERAN MEDICAL TECHNOLOGIES, INC INS-5410 04118191016 00815686020637

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Hospitalization FORCEPS - MODEL UNKNOWN.| INS-5300 ALWAYS-ON TIP TRACKED TRIPLE NEEDLE BRUSH.| SYS-4000 SPIN THORACIC NAVIGATION SYSTEM.