BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ASPIRATION NEEDLE

    MDR report key: 18944470 · Received March 20, 2024

    Report

    Report Number
    3011050570-2024-10042
    Event Type
    Injury
    Date Received
    March 20, 2024
    Date of Event
    January 1, 2024
    Report Date
    September 17, 2024
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    KTI
    PMA / PMN Number
    K163469
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS RELATED TO PATIENT IDENTIFIER (B)(6). THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE CORRECTION TO INITIAL MDR. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE REPORTED ISSUE CANNOT BE CONFIRMED. SINCE THERE WAS NO DETAILED INFORMATION ON THE USE OF THE DEVICE OR THE OCCURRENCE OF HEALTH HAZARDS IN THE LITERATURE, AND NO REPORTS OF MALFUNCTIONS OF THE PRODUCT, A CAUSAL RELATIONSHIP BETWEEN THE PRODUCT AND THE HEALTH HAZARDS COULD NOT BE IDENTIFIED. THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. THREE ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED FROM THE AUTHOR. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "ENDOBRONCHIAL ULTRASOUND-GUIDED MEDIASTINAL LYMPH NODAL CRYOBIOPSY IN PATIENTS WITH NONDIAGNOSTIC/INADEQUATE RAPID ON-SITE EVALUATION A NEW STEP IN THE DIAGNOSTIC ALGORITHM." LITERATURE SUMMARY: THIS PROSPECTIVE STUDY AIMED TO EVALUATE THE DIAGNOSTIC YIELD OF EBUS-GUIDED MEDIASTINAL CRYOBIOPSY (EBUS-MCB) IN PATIENTS WITH NONDIAGNOSTIC RAPID ON-SITE EVALUATION (ROSE). SECONDARY AIMS INCLUDED AN ASSESSMENT OF THE SAFETY OF THE PROCEDURE. A TOTAL OF 46 PATIENTS WERE INCLUDED. OF THE 46 CASES WHERE EBUS-MCB WAS PERFORMED, A DEFINITE DIAGNOSIS WAS ACHIEVED IN 33 (71.7%) CASES. OF THE 32 CASES WITH A NONDIAGNOSTIC ROSE, EBUS-MCB CONFIRMED THE DIAGNOSIS IN 19 (59.3%) CASES. THUS, THE ADDITIVE DIAGNOSTIC YIELD OF EBUS-MCB OVER EBUS-TBNA WAS IN 14/32 CASES (43.7%). THE ADDITIONAL TIME REQUIRED FOR PERFORMING CRYOBIOPSY IN THE STUDY WAS 11 ± 2 MINUTES. BACKGROUND: ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION (EBUS-TBNA) IS CONSIDERED THE INVESTIGATION OF CHOICE FOR SAMPLING MEDIASTINAL NODES. A MAJOR DRAWBACK OF EBUS-TBNA IS ITS LOWER DIAGNOSTIC YIELD FOR LYMPHOMA AND BENIGN DISEASES. EBUS-GUIDED MEDIASTINAL CRYOBIOPSY (EBUS-MCB) IS A NOVEL TECHNIQUE THAT PROVIDES LARGER NODAL BIOPSY SAMPLES, WITH AN ACCEPTABLE SAFETY PROFILE. THIS STUDY AIMED TO EVALUATE THE DIAGNOSTIC YIELD OF EBUS-MCB IN PATIENTS WITH AN INCONCLUSIVE RAPID ON-SITE EVALUATION (ROSE). METHODS: THIS IS A PROSPECTIVE STUDY OF PATIENTS WHO UNDERWENT EBUS-TBNA FOR UNDIAGNOSED MEDIASTINAL LYMPHADENOPATHY. PATIENTS IN WHOM ROSE DID NOT YIELD A DIAGNOSIS (NONDIAGNOSTIC ROSE) OR ROSE REVEALED SCANTY ATYPICAL CELLS (INADEQUATE ROSE) WERE SUBJECTED TO EBUS-MCB. THE DIAGNOSTIC YIELD, ADEQUACY, AND COMPLICATIONS OF EBUS-MCB WERE ANALYZED. RESULTS: OF THE 196 PATIENTS UNDERGOING EBUS-TBNA, 46 PATIENTS UNDERWENT EBUS-MCB. THIRTY-TWO CASES UNDERWENT EBUS-MCB FOR A NONDIAGNOSTIC ROSE. EBUS-MCB CONFIRMED THE DIAGNOSIS IN 19/32 (59.3%) CASES. THE ADDITIVE DIAGNOSTIC YIELD OF EBUS-MCB OVER EBUS-TBNA WAS 43.7% (14/32 CASES). IN ALL 14 CASES WHERE EBUS-MCB WAS PERFORMED FOR AN INADEQUATE ROSE, THE MATERIAL OBTAINED BY EBUS-MCB WAS ADEQUATE FOR ANCILLARY STUDIES. MINOR BLEED WAS NOTED IN 13/46 CASES, WHICH SETTLED WITH CONSERVATIVE MEASURES. ONE CASE HAD A MODERATE BLEED, REQUIRING A CRYOEXTRACTION OF THE BLOOD CLOT FROM THE AIRWAYS. CONCLUSION: EBUS-MCB HAS A DIAGNOSTIC YIELD OF 59.3% WHEN PERFORMED IN CASES WITH A NONDIAGNOSTIC EBUS-ROSE. THE TISSUE OBTAINED BY EBUS-MCB IS ADEQUATE FOR ANCILLARY STUDIES. THE STUDY PROPOSE EBUS-MCB AS AN ADDITIONAL DIAGNOSTIC STEP IN CASES WITH AN INCONCLUSIVE ROSE WHILE PERFORMING EBUS-TBNA. LARGER STUDIES ARE, HOWEVER, NEEDED BEFORE EBUS-MCB CAN BE INCORPORATED IN THE DIAGNOSTIC ALGORITHM FOR THE EVALUATION OF MEDIASTINAL LESIONS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS MILD BLEEDING (13), MODERATE BLEEDING (1).

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "ENDOBRONCHIAL ULTRASOUND-GUIDED MEDIASTINAL LYMPH NODAL CRYOBIOPSY IN PATIENTS WITH NONDIAGNOSTIC/INADEQUATE RAPID ON-SITE EVALUATION A NEW STEP IN THE DIAGNOSTIC ALGORITHM." LITERATURE SUMMARY: THIS PROSPECTIVE STUDY AIMED TO EVALUATE THE DIAGNOSTIC YIELD OF EBUS-GUIDED MEDIASTINAL CRYOBIOPSY (EBUS-MCB) IN PATIENTS WITH NONDIAGNOSTIC RAPID ON-SITE EVALUATION (ROSE). SECONDARY AIMS INCLUDED AN ASSESSMENT OF THE SAFETY OF THE PROCEDURE. A TOTAL OF 46 PATIENTS WERE INCLUDED. OF THE 46 CASES WHERE EBUS-MCB WAS PERFORMED, A DEFINITE DIAGNOSIS WAS ACHIEVED IN 33 (71.7%) CASES. OF THE 32 CASES WITH A NONDIAGNOSTIC ROSE, EBUS-MCB CONFIRMED THE DIAGNOSIS IN 19 (59.3%) CASES. THUS, THE ADDITIVE DIAGNOSTIC YIELD OF EBUS-MCB OVER EBUS-TBNA WAS IN 14/32 CASES (43.7%). THE ADDITIONAL TIME REQUIRED FOR PERFORMING CRYOBIOPSY IN THE STUDY WAS 11 ± 2 MINUTES. BACKGROUND: ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION (EBUS-TBNA) IS CONSIDERED THE INVESTIGATION OF CHOICE FOR SAMPLING MEDIASTINAL NODES. A MAJOR DRAWBACK OF EBUS-TBNA IS ITS LOWER DIAGNOSTIC YIELD FOR LYMPHOMA AND BENIGN DISEASES. EBUS-GUIDED MEDIASTINAL CRYOBIOPSY (EBUS-MCB) IS A NOVEL TECHNIQUE THAT PROVIDES LARGER NODAL BIOPSY SAMPLES, WITH AN ACCEPTABLE SAFETY PROFILE. THIS STUDY AIMED TO EVALUATE THE DIAGNOSTIC YIELD OF EBUS-MCB IN PATIENTS WITH AN INCONCLUSIVE RAPID ON-SITE EVALUATION (ROSE). METHODS: THIS IS A PROSPECTIVE STUDY OF PATIENTS WHO UNDERWENT EBUS-TBNA FOR UNDIAGNOSED MEDIASTINAL LYMPHADENOPATHY. PATIENTS IN WHOM ROSE DID NOT YIELD A DIAGNOSIS (NONDIAGNOSTIC ROSE) OR ROSE REVEALED SCANTY ATYPICAL CELLS (INADEQUATE ROSE) WERE SUBJECTED TO EBUS-MCB. THE DIAGNOSTIC YIELD, ADEQUACY, AND COMPLICATIONS OF EBUS-MCB WERE ANALYZED. RESULTS: OF THE 196 PATIENTS UNDERGOING EBUS-TBNA, 46 PATIENTS UNDERWENT EBUS-MCB. THIRTY-TWO CASES UNDERWENT EBUS-MCB FOR A NONDIAGNOSTIC ROSE. EBUS-MCB CONFIRMED THE DIAGNOSIS IN 19/32 (59.3%) CASES. THE ADDITIVE DIAGNOSTIC YIELD OF EBUS-MCB OVER EBUS-TBNA WAS 43.7% (14/32 CASES). IN ALL 14 CASES WHERE EBUS-MCB WAS PERFORMED FOR AN INADEQUATE ROSE, THE MATERIAL OBTAINED BY EBUS-MCB WAS ADEQUATE FOR ANCILLARY STUDIES. MINOR BLEED WAS NOTED IN 13/46 CASES, WHICH SETTLED WITH CONSERVATIVE MEASURES. ONE CASE HAD A MODERATE BLEED, REQUIRING A CRYOEXTRACTION OF THE BLOOD CLOT FROM THE AIRWAYS. CONCLUSION: EBUS-MCB HAS A DIAGNOSTIC YIELD OF 59.3% WHEN PERFORMED IN CASES WITH A NONDIAGNOSTIC EBUS-ROSE. THE TISSUE OBTAINED BY EBUS-MCB IS ADEQUATE FOR ANCILLARY STUDIES. THE STUDY PROPOSE EBUS-MCB AS AN ADDITIONAL DIAGNOSTIC STEP IN CASES WITH AN INCONCLUSIVE ROSE WHILE PERFORMING EBUS-TBNA. LARGER STUDIES ARE, HOWEVER, NEEDED BEFORE EBUS-MCB CAN BE INCORPORATED IN THE DIAGNOSTIC ALGORITHM FOR THE EVALUATION OF MEDIASTINAL LESIONS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: MILD BLEEDING (13), MODERATE BLEEDING (1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1984887 SINGLE USE ASPIRATION NEEDLE VIZISHOT 2 FLEX KTI GYRUS ACMI, INC. NA-U403SX-4019 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention BF-UC180F