BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELEPORT MICROCATHETER

    MDR report key: 8446665 · Received March 24, 2019

    Report

    Report Number
    3003775186-2019-00004
    Event Type
    Malfunction
    Date Received
    March 24, 2019
    Date of Event
    February 26, 2019
    Report Date
    March 24, 2019
    Manufacturer
    ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
    Product Code
    DQY
    UDI-DI
    06934955943072
    PMA / PMN Number
    K182360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT PRODUCT, TELEPORT MICROCATHETER 2.1F X 135CM AND ASSOCIATED WIRE, WERE RETURNED FOR EVALUATION. PER GROSS EXAMINATION: DRIED BLOOD COULD BE FOUND IN THE RETURNED DEVICES. THERE WERE SEVERELY STRETCHED AND DAMAGED WERE FOUND IN THE (PROXIMAL AND DISTAL) SHAFT OF TELEPORT MICROCATHETER. MEASURED THE STRETCHED CATHETER (PROXIMAL AND DISTAL) SHAFT AND CONFIRMED THAT IT HAS BEEN STRETCHED APPROXIMATELY 9.0CM. MICROSCOPIC EXAMINATION REVEALED THAT THE DISTAL TIP OF THE TELEPORT MICROCATHETER WAS STILL INTACT, BUT HAS BEEN DEFORMED AND SEVERELY DAMAGED WITH THE FLARING DISPLAYED. DAMAGED CATHETER OUTER BODY AND DEFORMED COIL AND EXPOSED BRAIDED WIRE WERE FOUND ON THE CATHETER SHAFT WITH SIGNIFICANT SIGNS OF STRETCHING, AND THE FAILURE MODE/APPEARANCE IS CONSISTENT WITH DAMAGE OF BEING TRAPPED BY SOME HARD OBJECTS AND ROTATION. APART FROM ABOVE OBSERVED DAMAGE, NO OTHER ANOMALIES WERE FOUND ON THE RETURNED DEVICE. NO ABNORMALITY WAS FOUND ON THE ASSOCIATED WIRE WHEN THE WIRE WAS REMOVED FROM THE TELEPORT CATHETER. AN ASSOCIATED CLINICAL PICTURE WAS PROVIDED FOR ANALYSIS AND THE PICTURE APPEARS TO SHOW THAT THE PROXIMAL SHAFT OF THE MICROCATHETER BECOME STRETCHED. A REVIEW OF THE CLINICAL INFORMATION FOR THIS COMPLAINT INDICATED THAT A CATHETER (TELEPORT 2.1F X 135CM / LOT# 4307301811) COULD NOT BE ADVANCED INTO THE LESION IN THE MID-CIRCUMFLEX ARTERY. TORQUE WAS APPLIED AND THE MICROCATHETER BECAME STUCK ON THE GUIDE WIRE. THE CATHETER AND WIRE WERE THEN REMOVED AND THE MICROCATHETER APPEARED TO BE FRAYED, BUT THE TIP WAS STILL ATTACHED. THE DAMAGE ON THE TELEPORT MICROCATHETER WAS NOT DUE TO A MANUFACTURING ASSEMBLING FAILURE. THE FAILURE MODE/APPEARANCE OF THE TELEPORT MICROCATHETER IS CONSISTENT DAMAGE DUE TO TRAPPED WITH AN EXTERNAL HARD OBJECT (SEVERE CALCIFICATION) OR OTHER DEVICES (SUCH AS ASSOCIATED GUIDEWIRE) AND FURTHER ELONGATED BY EXCESSIVE PULLING FORCE. THERE ARE NO SIGNS OF MANUFACTURING DEFECTS ON THE RETURNED PRODUCT AND / OR THE LOT INFORMATION FROM THIS PRODUCT. BASED ON THE ABOVE INVESTIGATION, THE POSSIBLE ROOT CAUSE IDENTIFIED IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURE FACTORS. NO REMEDIAL ACTION IS BEING PERFORMED BY ORBUSNEICH IN RESPONSE TO THIS EVENT AT THIS TIME.

    Description of Event or Problem · 1

    THE TELEPORT CONTROL MICROCATHETER COULD NOT BE ADVANCED INTO THE LESION IN THE MID-CIRCUMFLEX ARTERY. TORQUE WAS APPLIED AND THE MICROCATHETER BECAME STUCK ON THE GUIDE WIRE. THE CATHETER AND WIRE WERE THEN REMOVED AND THE MICROCATHETER APPEARED TO BE FRAYED, BUT THE TIP WAS STILL ATTACHED. THE VESSEL WAS 95% STENOTIC WITH A DIAMETER OF 3.5MM AND SEVERE CALCIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239668 TELEPORT MICROCATHETER MICROCATHETER DQY ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. 4307301811 06934955943072

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening