BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELEPORT MICROCATHETER

    MDR report key: 8661180 · Received June 1, 2019

    Report

    Report Number
    3003775186-2019-00006
    Event Type
    Malfunction
    Date Received
    June 1, 2019
    Date of Event
    April 19, 2019
    Report Date
    June 1, 2019
    Manufacturer
    ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THERE IS NO EVIDENCE OF A PRODUCT MALFUNCTION, INADEQUACY IN THE IFU, OR A MANUFACTURING DEFECT. THE INSTRUCTIONS FOR USE INCLUDE THE FOLLOWING WARNING: "IF ABNORMAL RESISTANCE IS DETECTED DURING USE OF THIS PRODUCT, DO NOT CONTINUE THE OPERATION, AVOID EXCESSIVE MANIPULATIONS, AND CAREFULLY REMOVE THE ENTIRE CATHETER SYSTEM WHILE PAYING FULL ATTENTION TO AVOID COMPLICATIONS. CONTINUING THE OPERATION WHILE THE CAUSE OF THE PROBLEM IS NOT IDENTIFIED MAY CAUSE DAMAGE TO OR RUPTURE OF THE CATHETER, AND DAMAGE THE BLOOD VESSEL. IN THE WORST CASE, LIFE-THREATENING ADVERSE EVENTS MAY OCCUR." THE INSTRUCTIONS FOR USE ALSO INCLUDE THE FOLLOWING PRECAUTION: "DO NOT USE IN ADVANCED CALCIFIED LESIONS." NO REMEDIAL ACTION IS BEING PERFORMED BY (B)(4) IN RESPONSE TO THIS EVENT AT THIS TIME.

    Description of Event or Problem · 1

    A CORSAIR AND GW (JUPITER FC) COULD NOT CROSS THE LESION. THE DEVICE OF TELEPORT WAS ALTERNATIVELY DELIVERED BUT COULD NOT CROSS THE LESION EITHER. A JADE 2.0X 240MM (OMKK#744) WAS ALTERNATIVELY DELIVERED BUT COULD NOT CROSS THE LESION EITHER. AFTER A COYOTE 1.5 X 20MM WAS ATTEMPTED TO INFLATE BUT RUPTURED AND A JADE 1.5 X 40MM WAS INFLATED WITH NO PROBLEMS A JADE (OMKK#745) WAS ALTERNATIVELY USED BUT RUPTURED AT 6ATM. THE DEVICE OF TELEPORT PREVIOUSLY USED WAS INSERTED AGAIN AND DELIVERED BUT GOT STUCK WITH THE GW. DISTALLY PUNCTURED TO PULL OUT THE GW BUT FAILED SO A CROSSER WAS ATTEMPTED TO BE INSERTED BUT FAILED. NEWLY PUNCTURED PROXIMALLY TO INSERT A STIFFER GW BUT THE GW STUCK COULD NOT BE REMOVED. A VASSALL WIRE WAS DELIVERED IN A FALSE LUMEN AND A JADE 30 X 40M WAS DELIVERED AND INFLATED NEAR THE TELEPORT STUCK THEN USING A GUIDELINER BY PUSHING THE TELEPORT AND GW WERE EVENTUALLY WITHDRAWN. THE PROCEDURE TOOK 4 HOURS AND WAS ABORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454608 TELEPORT MICROCATHETER MICROCATHETER DQY ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. 4307471811

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening