BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELEPORT MICROCATHETER

    MDR report key: 8446667 · Received March 24, 2019

    Report

    Report Number
    3003775186-2019-00002
    Event Type
    Malfunction
    Date Received
    March 24, 2019
    Date of Event
    March 8, 2019
    Report Date
    March 24, 2019
    Manufacturer
    ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
    Product Code
    DQY
    PMA / PMN Number
    K182360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DETAIL CASE DESCRIPTION REVEALED A TELEPORT 2.0F X 135CM MICROCATHETER WAS USED TO SUPPORT A JUPITER FC GW AND AFTER THE GW CROSSED IT GOT STUCK WHEN THE TELEPORT WAS PUSHED TO ADVANCE, THE TELEPORT WAS REMOVED OUTSIDE THE BODY AND IT WAS FOUND THE RADIOPAQUE TIP WAS MISSING AND REMAINED IN THE BODY. THEN THE TIP WAS FLUOROSCOPICALLY OBSERVED AT THE ANKLE SITE SO A 2.0MM BALLOON CATHETER (BOSTON COYOTE) WAS DELIVERED TO THE SITE, INFLATED AND PULLED BACK COLLECTING THE TIP TO OUTSIDE THE BODY. THE PROCEDURE WAS CONTINUED AND COMPLETED WITH NO PATIENT INJURY. THE DEVICE INCLUDING THE TIP WAS DISCARDED AT THE HOSPITAL. SINCE NEITHER THE INVOLVED DEVICES NOR THE CLINICAL IMAGES / CD OF THE PROCEDURE WERE PROVIDED FOR ANALYSIS, THE INVESTIGATION WAS LIMITED TO THE REVIEW OF OUR FACILITY QUALITY RECORDS. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS BATCH (4305011809) DID NOT REVEAL ANY NON-CONFORMITY WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT. A LOT HISTORY REVIEW OF THE MICROCATHETER WAS CONDUCTED AND NO MANUFACTURING RELATED CAUSES COULD BE FOUND FOR THIS COMPLAINT. ORBUSNEICH MEDICAL MANUFACTURING PROCESSES INCLUDE EXTENSIVE TESTING AND INSPECTIONS TO ENSURE EACH PRODUCT MEETS ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS PRIOR TO RELEASE. ADDITIONALLY, NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED FROM THIS BATCH. ACCORDING TO THE ABOVE INVESTIGATION, NO MANUFACTURING DEFECTS WERE FOUND IN THE REVIEW OF MANUFACTURING RECORDS OF THIS BATCH OF PRODUCTS. BASED ON THE OBTAINED INFORMATION, IT WAS PRESUMED THAT TORSION / EXTERNAL FORCE APPLIED TO THE MICROCATHETER EXCEEDED THE PRODUCT'S DESIGN LIMIT WHILE THE TIP WAS BEING TRAPPED BY THE HEAVY CALCIFIED / TORTURED / STENOSED LESION (RIGHT SFA MID LESION), CAUSING DAMAGE TO THE TIP. THE DAMAGED TIP WAS ASSUMED TO BE SEPARATED BY TENSILE STRESS APPLIED UPON CATHETER REMOVAL FROM THE LESION. HOWEVER, DETAILS COULD NOT BE ASCERTAINED AS THE DEVICE EVALUATION COULD NOT BE PERFORMED. NO REMEDIAL ACTION IS BEING PERFORMED BY ORBUSNEICH IN RESPONSE TO THIS EVENT AT THIS TIME.

    Description of Event or Problem · 1

    A 6 FR DESTINATION WAS CROSSED OVER FROM THE LEFT FEMORAL AND A TELEPORT WAS USED TO SUPPORT A JUPITER FC GW. AFTER THE GW CROSSED WHEN THE TELEPORT WAS PUSHED TO ADVANCE IT GOT STUCK. THE TELEPORT WAS REMOVED OUTSIDE THE BODY AND IT WAS FOUND THE RADIOPAQUE TIP WAS MISSING AND REMAINED IN THE BODY. THEN THE TIP WAS FLUOROSCOPICALLY OBSERVED AT THE ANKLE SITE SO A 2MM BALLOON CATHETER (BOSTON COYOTE) WAS DELIVERED TO THE SITE, INFLATED AND PULLED BACK COLLECTING THE TIP TO OUTSIDE THE BODY. THE PROCEDURE WAS CONTINUED AND COMPLETED WITH NO PATIENT INJURY. THE DEVICE INCLUDING THE TIP WAS DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239662 TELEPORT MICROCATHETER MICROCATHETER DQY ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. 4305011809

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention