BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELEPORT MICROCATHETER

    MDR report key: 8446663 · Received March 24, 2019

    Report

    Report Number
    3003775186-2019-00003
    Event Type
    Malfunction
    Date Received
    March 24, 2019
    Date of Event
    February 26, 2019
    Manufacturer
    ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
    Product Code
    DQY
    UDI-DI
    06934955943065
    PMA / PMN Number
    K182360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DRIED BLOOD COULD BE FOUND IN THE RETURNED DEVICE. 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 11.5CM. MICROSCOPIC EXAMINATION REVEALED THAT THE DISTAL TIP OF THE TELEPORT MICROCATHETER WAS STILL INTACT, BUT HAS BEEN DEFORMED AND SLIGHTLY DAMAGED WITH 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. AN ASSOCIATED CLINICAL PICTURE WAS PROVIDED FOR ANALYSIS AND THE PICTURE APPEARS TO SHOW THAT THE PROXIMAL SHAFT / DISTAL SHAFT / DISTAL TIP OF THE MICROCATHETER BECOME STRETCHED AND DAMAGED. A REVIEW OF THE CLINICAL INFORMATION FOR THIS COMPLAINT INDICATED THAT A CATHETER (TELEPORT 2.0F X 150CM / LOT# 4307271811) COULD NOT CROSS THE LESION AND BECAME STUCK AT THE SAME LOCATION AS THE PREVIOUS DEVICE. ADDITIONAL FORCE WAS APPLIED TO REMOVE THE MICROCATHETER AND THE MICROCATHETER FRACTURED AND STRETCHED DURING REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANGIOPLASTY AND ATHERECTOMY. DURING THE MANUFACTURING PROCESSES EACH MICROCATHETER IS INSERTED TO A 0.0155" X 1800MM MANDREL TO INSPECT AND ENSURE WITHOUT OBVIOUS FRICTION PRIOR TO PROCEED TO NEXT PROCESS. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS BATCH (4307271811) 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. THE RETURNED TELEPORT MICROCATHETER WAS EXAMINED IN THE FAILURE ANALYSIS LABORATORY. THE ANALYSIS RESULTS ARE: 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 MICROCATHETER COULD NOT CROSS THE LESION AND BECAME STUCK AT THE SAME LOCATION AS THE PREVIOUS DEVICE. ADDITIONAL FORCE WAS APPLIED TO REMOVE THE MICROCATHETER AND THE MICROCATHETER FRACTURED AND STRETCHED DURING REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANGIOPLASTY AND ATHERECTOMY. 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
    239661 TELEPORT MICROCATHETER MICROCATHETER DQY ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. 4307271811 06934955943065

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening