BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METACROSS RX PTA BALLOON DILATATION CATHETER

    MDR report key: 9195181 · Received October 15, 2019

    Report

    Report Number
    3002808904-2019-00028
    Event Type
    Injury
    Date Received
    October 15, 2019
    Date of Event
    September 10, 2019
    Report Date
    September 17, 2019
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LIT
    PMA / PMN Number
    K150865
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCERNED DEVICE "METACROSS RX" IS A RAPID EXCHANGE (RX) TYPE PTA BALLOON DILATATION CATHETER COMPATIBLE TO 0.035" GUIDEWIRE (GW). "METACROSS RX" IS DISTRIBUTED IN THE US UNDER 510(K) # K150865. THE DEVICE HISTORY RECORDS (DHR - BATCH RECORD) OF THE CONCERNED DEVICE WAS REVIEWED AND NO NONCONFORMITY OR ABNORMALITY IN THE MANUFACTURING PROCESSES WAS FOUND. THE CONCERNED DEVICE, METACROSS RX, WAS RETURNED TOGETHER WITH THE SHEATH AND GW USED, AND WAS INVESTIGATED: THE BALLOON WAS STUCK ON THE SHEATH TIP. WHEN THE BALLOON WAS CAREFULLY REMOVED FROM THE SHEATH, THE BALLOON WAS WRINKLED TOWARD THE TIP SIDE. THERE WAS NO EVIDENCE OF BALLOON DESTRUCTION. THE CATHETER WAS BROKEN AT 1140MM FROM THE TIP. IT WAS CONFIRMED THAT ALL BALLOON CATHETERS WERE COLLECTED. THE TOTAL LENGTH OF THE BROKEN BALLOON CATHETER WAS ABOUT 1705 MM AND WAS EXTENDED ABOUT 350 MM. (PRODUCT STANDARD IS 1350MM) DEFORMATION WAS SEEN AT THE SHEATH TIP. PROBABLE CAUSE AND COMMENTS: WE SPECULATE THE REPORTED SITUATION AS FOLLOWS: THE FRICTIONAL RESISTANCE BETWEEN THE BALLOON AND THE SHEATH TIP INCREASED DUE TO THE INFLOW OF BLOOD, AND THE SHAFT STUCK, AND THE SHAFT BROKE DUE TO EXCESSIVE PULLING FORCE. NO NONCONFORMITY OR ABNORMALITY WAS FOUND IN THE MANUFACTURING PROCESSES ACCORDING TO THE DHR. WE BELIEVE THE REPORTED PROBLEM WOULD NOT BE CAUSED BY ANY DEFECT OF THE DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER USED A METACROSS RX 7X60 TRANSBRACHIAL OVER A 6FR DESTINATION 90CM. AFTER DILATATION, THE DEFLATED BALLOON SHOULD BE REMOVED FROM THE VESSEL. THE BALLOON DID NOT GO WELL THROUGH THE SHEATH AND WAS FINALLY DEMOLISHED. A PIECE OF THE BALLOON GOT STUCK AT THE END OF THE SHEATH. THE SHEATH WITH THE BALLOON REST WAS RECOVERED TO THE ELBOW AND THE REST WAS THEN RECOVERED SURGICALLY. THERE ARE NO PARTS OF THE PRODUCT LEFT IN THE PATIENT. IN ADDITION TO THE INTERVENTION, A SURGICAL PROCEDURE HAD TO BE PERFORMED IN ORDER TO BE ABLE TO REMOVE THE REST OF THE BALLOON AS DESCRIBED ABOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986693 METACROSS RX PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL, LIT KANEKA CORPORATION SP118349

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention