BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONCONTROL COAXIAL BIOPSY TRAY 11/13 GA

    MDR report key: 9397236 · Received December 2, 2019

    Report

    Report Number
    3011137372-2019-00395
    Event Type
    Malfunction
    Date Received
    December 2, 2019
    Date of Event
    October 31, 2019
    Report Date
    November 6, 2019
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FCG
    PMA / PMN Number
    K113872
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DHR IS NOT AVAILABLE FOR REVIEW. RECEIVED THE FOLLOWING COMPONENTS FROM 9464-VC-004, ONCONTROL COAXIAL BIOPSY TRAY 11/13 GA....BONE ACCESS NEEDLE SET, BONE ACCESS EJECTOR ROD, BONE LESION BIOPSY NEEDLE, BONE LESION BIOPSY EJECTOR ROD, TRANSFER ROD. AT VISUAL INSPECTION THE REPORTED DEFECT WAS CONFIRMED: THE 13 GA. BONE LESION BIOPSY NEEDLE HAS BEEN BROKEN OFF. UNDER MAGNIFICATION THE BREAK APPEARS TO HAVE TWISTED OFF. A SECTION OF THE IFU WILL BE REFERENCED AS PART OF THIS INVESTIGATION REPORT. THE IFU STATES, " INSERT BONE ACCESS NEEDLE SET INTO INTENDED LOCATION USING THE CORRECT ANGLE. ATTACH DRIVER TO NEEDLE SET. WHEN CORRECTLY INSERTED, THE NEEDLE SET WILL SECURE INTO CONNECTOR WITH A "CLICK". TIGHTEN STYLET AND HUB OF THE BONE ACCESS NEEDLE SET. FIND LOCATION ON BONE, NOTE DEPTH MARKING AND SQUEEZE TRIGGER TO ACTIVATE DRIVER. DO NOT APPLY EXCESSIVE FORCE TO DRIVER/NEEDLE SET. SQUEEZE TRIGGER UNTIL BONE ACCESS NEEDLE SET HAS REACHED THE DESIRED LOCATION TO BE BIOPSIED. DETACH POWER DRIVER FROM THE BONE ACCESS NEEDLE SET. DETACH POWER DRIVER FROM THE BONE LESION BIOPSY NEEDLE SET. REMOVE STYLET. IF NEEDED, USE THE MANUAL HANDLE FOR MINOR ADJUSTMENTS OF THE BONE ACCESS CANNULA. BONE LESION BIOPSY NEEDLE SET SHOULD ALWAYS BE USED INSIDE THE ACCESS NEEDLE. DO NOT USE THE BONE LESION BIOPSY NEEDLE SET INDEPENDENTLY OF THE ACCESS NEEDLE. PLACE THE BONE LESION BIOPSY NEEDLE INSIDE THE BONE ACCESS CANNULA. FOR BONE LESION, ATTACH POWER DRIVER TO BONE LESION BIOPSY NEEDLE HUB, USE DEPTH MARKERS AS GUIDE. IN ONE CONTINUOUS MOTION, SQUEEZE TRIGGER, AND ADVANCE BONE LESION BIOPSY NEEDLE (UP TO 1.5 CM AS ALLOWED BY THE BONE ACCESS CANNULA); WITH THE TRIGGER STILL ENGAGED, PULL UP ON POWER DRIVER UNTIL BONE LESION BIOPSY NEEDLE IS COMPLETELY REMOVED FROM PATIENT. THE CERTIFICATE OF COMPLIANCE COULD NOT BE REVIEWED AS THE REPORTED LOT/BATCH IS NOT VALID. THE COMPLAINT HAS BEEN CONFIRMED. HOWEVER, THE LACK OF DOCUMENTED DETAIL AND/OR PICTURES OF THE INCIDENT PREVENTS A DEFINITIVE ROOT CAUSE ASSIGNMENT. NO CORRECTIVE/PREVENTATIVE ACTIONS WILL BE ASSIGNED. THE COMPLAINT HAS BEEN CONFIRMED. CLOSE UP PHOTOS REVEAL THE TWISTED METAL END OF THE LESION BIOPSY NEEDLE. OBVIOUSLY, THE BIOPSY NEEDLE WAS IN A VERY HARD MATTER, BUT WHETHER OR NOT THE PROPER NEEDLE RETRIEVAL TECHNIQUE WAS PRACTICED, OR IF THE CORRECT MANUAL NEEDLE REMOVAL TECHNIQUE TO REMOVE A NEEDLE WAS EXECUTED CANNOT BE DETERMINED. THE BREAKAGE DOES NOT REFLECT ANY CHARACTERISTICS THAT WOULD POINT TO A MANUFACTURING MATERIAL OR PROCESS DEFICIENCY. THE COMPLAINT HAS BEEN CONFIRMED, HOWEVER A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED.

    Description of Event or Problem · 0

    THE REPORT STATES, BROKEN DURING USE. AS STATED BY THE PHYSICIAN, THE INNER 13-GAUGE NEEDLE SNAPPED WHILE ADVANCING IT AT AN ANGLE. ALL COMPONENTS RETRIEVED AND BIOPSY SUCCESSFUL. THE LOCATION OF THE LESION WAS L5 ENDPLATE, SUPERIOR ENDPLATE OF S1 AND L5-S1 DISC ASPIRATE ALSO PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVESTIGATION IS PENDING. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    THE REPORT STATES, BROKEN DURING USE. AS STATED BY THE PHYSICIAN, THE INNER 13-GAUGE NEEDLE SNAPPED WHILE ADVANCING IT AT AN ANGLE. ALL COMPONENTS RETRIEVED AND BIOPSY SUCCESSFUL. THE LOCATION OF THE LESION WAS L5 ENDPLATE, SUPERIOR ENDPLATE OF S1 AND L5-S1 DISC ASPIRATE ALSO PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1191835 ONCONTROL COAXIAL BIOPSY TRAY 11/13 GA BIOPSY NEEDLE KIT FCG TELEFLEX MEDICAL 33783372

    Patients

    Seq Age Sex Outcome Treatment
    1